GARLICPUREE.COM
MASTER FSVP POLICY
GARLICPUREE.COM | FOREIGN SUPPLIER VERIFICATION PROGRAM
Frozen IQF garlic puree • China origin
Don Il Chang DBA GarlicPuree.com
Document: GP-FSVP-001 | Revision: 1.0 | Prepared: 09/08/2026
Status: Final — Approved and Adopted | Effective date: 09/08/2026
Policy owner / proposed FSVP qualified individual: Don Il Chang
Contact: Don@GarlicPuree.com | D-U-N-S: 118880823
1. Policy statement
GarlicPuree.com shall develop, maintain, and follow an FSVP for its imported frozen garlic puree that provides adequate assurance of compliance with applicable U.S. food safety and major-allergen labeling requirements. Procurement pressure, supplier relationships, pricing, and freight commitments shall not override a documented food safety hold. [R1: §§ 1.502, 1.512]
This policy is built around the owner’s stated very small importer status under 21 CFR 1.512(a)(1). It combines the applicable modified FSVP requirements with additional company requirements for factory qualification, product review, testing, shipment release, and traceability. It does not claim that a supplier, lot, or completed FSVP has been independently verified through preparation of this document.
2. Scope and operating model
Scope: one frozen IQF garlic puree product, approximately 20 g portions, manufactured in China by Manufacturing Company, purchased through Contracted Exporter. The exact factory legal name, address, and product specification shall be tied to the signed supplier file.
GarlicPuree.com operates as an importer and supplier. Manufacturing and physical logistics are performed by contracted parties. Product is delivered to contracted frozen storage or customer facilities; this policy does not establish manufacturing or food storage at the importer’s home office.
This is an internal operating policy, not website copy or a supplier certificate. Blank forms in the appendices become compliance evidence only after completion, review, signature, and dating.
Approval
Approved by: Don Il Chang, Owner / FSVP Program Lead
Signature: DON IL CHANG Date: 09/08/2026
3. Regulatory pathway and responsibilities
Applicable modified requirements
While documented very small importer eligibility applies, GarlicPuree.com shall comply with §§ 1.502, 1.503, 1.509, and 1.512(b). Under § 1.512(b)(2), §§ 1.504–1.508 and 1.510 are not required for this pathway. Required corrective actions and recordkeeping instead arise under § 1.512(b)(4)–(5). Section 1.512(c) is for importers who are not very small importers and rely on certain small foreign suppliers; it is not the basis of this policy. [R1]
Company requirements in this policy supplement that legal baseline. The company does not claim that FSVP universally requires a BRCGS Grade A certificate, testing of every shipment, or a specific garlic dry matter percentage. Once adopted, the additional requirements are internal commitments.
Accountability
| Role | Assigned responsibility |
|---|---|
| Don Il Chang | Own the program; document eligibility; approve the factory, specification, testing plan, holds, releases, corrective actions, and revisions. |
| FSVP qualified individual (QI) | Perform assigned FSVP work based on documented education, training, or experience; understand records or obtain competent translations. Maintain qualification evidence. |
| Manufacturing Company manufacturing facility | Produce compliant food; provide the signed assurance, factory records, lot identity, test documentation, and prompt change/incident notification. |
| Contracted Exporter | Coordinate purchasing and factory documentation; preserve Manufacturing Company identity and traceability; obtain advance approval for proposed changes. |
| T Customs Broker / ACC | Perform assigned entry and transport tasks. T Customs Broker and American Cargo Care do not replace the importer’s FSVP responsibility. |
| Warehouse / customer receiver | Maintain frozen handling, lot identification, receipt checks, stock holds, and traceable shipment records under agreed instructions. |
Don’s reported PCQI and manufacturing experience shall be documented in the QI file. PCQI training alone shall not be treated as proof of competence for every FSVP task. A qualified substitute must be designated before delegated approvals occur. The foreign facility’s U.S. registration agent is distinct from the FSVP importer. [R1: §§ 1.500, 1.503]
Business address: 1327 S. WILTON PL. LOS ANGELES CA 90019
Telephone: 323-317-1510
4. Very small importer eligibility
The owner shall document eligibility before first importation under this pathway and annually by December 31. Use the human-food definition in § 1.500, not profit, customs value alone, imported garlic sales alone, or a per-container threshold. [R1: § 1.512(b)(1)]
Annual determination procedure
Identify the legal importer and all subsidiaries and affiliates that must be included. Document the ownership/control assessment. Employment by, or sales to, Chang Food Group does not by itself settle the affiliate analysis.
Compile sales of human food plus the U.S. market value of human food imported, manufactured, processed, packed, or held without sale for the applicable lookback period. Document valuation methods and avoid double counting.
Retain financial records, calculations, assumptions, and the dated FDA inflation-adjustment table. For non-U.S.-dollar sales, apply the required December 31 exchange rate for the year of sale.
For a startup without prior-year records, FDA guidance permits a credible projected revenue/market-value estimate at commencement. Keep its assumptions and supporting evidence. Once one or two preceding calendar years are available, calculate using those records. Do not invent historical revenue or unsupported zero years. [R3: Question L.9]
Sign the annual determination and set the next review date. Review sooner after ownership, affiliation, business-scope, or material revenue changes.
FDA’s current table lists a human-food very small importer three-year average cutoff of $1,372,952 for 2023–2025, used for the 2026 assessment. Eligibility requires an average below the applicable cutoff. Save the table used and recheck annually. [R2]
Supporting eligibility calculations and financial records are maintained as controlled internal records and are available promptly to authorized FDA representatives upon request. Company-specific financial figures are not published in this public copy.
If eligibility is not supported
Do not continue claiming modified status without a documented basis. Before affected imports, the QI shall establish the appropriate FSVP pathway. A full-pathway transition requires a written hazard analysis (§ 1.504), food/supplier evaluation and reevaluation (§ 1.505), supplier approval and verification procedures (§ 1.506), any applicable downstream-control determination (§ 1.507), corrective actions (§ 1.508), and records (§ 1.510).
For full FSVP, supplier-controlled hazards with a reasonable probability of serious adverse health consequences or death generally trigger initial and annual onsite auditing unless the documented regulatory alternative is justified. This is a contingency requirement, not a blanket annual-audit rule imposed on the current very small importer pathway. [R1: § 1.506(d)]
5. Product identity and intended use
Controlled product profile
| Attribute | Policy basis / controlled record |
|---|---|
| Food | Frozen IQF garlic puree; China origin; nominal 20 g portions. |
| Manufacturer / exporter | Manufacturing Company / Contracted Exporter; confirm exact legal names and addresses. |
| Ingredients / added water | Signed current formulation governs. Prior records conflict between garlic plus water and 100% garlic. Do not claim 0% added water until resolved. |
| Packaging | Latest owner-stated commercial format: 20 lb cases; 100 cases / 2,000 lb pallet. Older supplier records cite 10 kg cases. Reconcile the actual contracted shipping format before release. |
| Storage | Maintain frozen at −18°C or colder under the approved specification. Operational shorthand: 0°F or colder. |
| Shelf life | Use only the approved, supported shelf life and date basis. A prior 24-month supplier statement is not a new validation or extension authorization. |
| Intended use | Industrial raw ingredient for further processing; not assumed ready-to-eat or subject to a validated supplier lethality step. |
Use restrictions and buyer communication
The QI shall obtain the actual process flow and determine whether any supplier treatment is validated to control identified pathogens. IQF freezing, washing, intrinsic garlic activity, or a negative COA shall not be represented as a validated kill step.
Until ready-to-eat suitability is separately established, specifications, sales materials, samples, and accompanying documents shall identify the product as requiring further processing. Uncooked dressing, dip, garnish, or other no-kill applications require technical review before sale. A broker or distributor shall pass the use restriction to the receiving customer.
Where the QI identifies uncontrolled Salmonella and Listeria monocytogenes, use a corresponding hazard-specific disclosure, such as: “Not processed to control Salmonella or Listeria monocytogenes. For further processing with a validated pathogen control. Keep frozen.” Record the final wording and technical basis; do not substitute a generic use statement for a hazard-specific disclosure when relying on § 1.507.
The current policy relies on § 1.512, not a claimed § 1.507 exemption. Any future reliance on downstream controls under § 1.507 requires a separate written determination covering the applicable conditions and current FDA policy. [R1; R3]
6. Factory qualification and change control
Approve the actual manufacturing facility
The foreign supplier is the establishment that manufactures/processes the food within the FSVP definition, not automatically the invoicing exporter. The QI shall identify the establishment performing the relevant processing and keep its name consistent across the supplier register, assurance, specification, and lot records. [R1: § 1.500]
Manufacturing Company is the designated manufacturer for this program. Prior manufacturer records shall be retained as historical records, not reused as Manufacturing Company evidence. Retain the executed manufacturer-change agreement under Contract [reference retained in controlled contract records] and the referenced purchasing specification “[title retained in controlled purchasing records],” including Section 14. That document title does not establish ISO certification.
Required company qualification package
Factory legal name, full physical address, contacts, current registration evidence and identifiers where applicable, and exporter-to-factory relationship.
Current BRCGS certificate showing site, scope, grade, validity, and issuing body; full relevant audit findings and corrective-action closure. Verify claimed Grade A against the actual certificate.
Process flow, hazard controls, water quality, sanitation, personnel hygiene, environmental controls appropriate to the process, foreign-material controls, and allergen cross-contact assessment.
Current signed specification, ingredient statement, packaging declaration, lot code explanation, recall/traceability procedure, and supporting analytical records.
Documented check of relevant FDA warning letters, import alerts, refusals, recalls, and other compliance information, using factory aliases and addresses as appropriate.
Complete a signed decision: Approved, Pending, Suspended, or Rejected, with scope, evidence references, conditions, and next review date. A certificate alone does not establish U.S. compliance. FDA registration is not FDA approval.
No unapproved substitutions
Contracted Exporter shall disclose proposed changes to manufacturer, site, subcontractor, ingredients, added water, process, agricultural sourcing, specification, packaging, or lot coding before affected production/shipment. The QI shall review the safety and traceability impact and approve in writing before shipment authorization. Purchasing staff shall match the factory to the approved register for every order.
Review qualification at least annually and promptly following a material change, audit failure, regulatory action, complaint, test failure, or traceability concern. These frequencies are company requirements under the chosen modified pathway.
7. Supplier assurance and product risk review
Mandatory written supplier assurance
Before importing the food and at least every two years thereafter, obtain written assurance from the foreign supplier that the food is produced under processes and procedures providing at least the same level of public health protection as applicable FD&C Act § 418 or § 419 and implementing regulations, and complies with § 402 and § 403(w), if applicable. Use Appendix B or an equivalent signed statement. [R1: § 1.512(b)(3)(i)]
The assurance shall identify Manufacturing Company’s actual site and the garlic puree covered. A Contracted Exporter sales statement or COA is not a substitute unless it conveys an authorized assurance attributable to the actual foreign supplier. Record receipt, QI acceptance, and renewal due date; obtain a new assurance for a new manufacturing site.
Company risk review: required before supplier release
The following is a product-specific screening framework, not a completed § 1.504 hazard analysis. The QI shall record occurrence evidence, severity, likelihood without controls, control owner, and verification rationale using the actual process and intended use. [R1: § 1.504; R4]
| Hazard group | Review and control evidence |
|---|---|
| Salmonella; pathogenic E. coli | Raw garlic, water, handling, and cross-contamination; supplier agricultural/water/sanitation controls, relevant testing, and documented downstream lethality where needed. |
| Listeria monocytogenes | Wet processing and equipment/environment contamination; sanitation and environmental program appropriate to the process; no assumption that freezing eliminates contamination. |
| Spore-formers / toxin formation | Evaluate C. botulinum, B. cereus, and S. aureus as appropriate to formulation, packaging, and temperature abuse. Address thawed holding and oxygen-restricted/oil-containing use; cooking is not a blanket rescue for preformed toxin. |
| Pesticides / heavy metals | Agricultural chemical use and source contamination; targeted panel and U.S. applicability assessment. Define analytes, limits, methods, and detection capability. |
| Allergens / undeclared additions | Review all ingredients, processing aids, rework, shared equipment, and label declarations. Assess relevant U.S. major allergens and unauthorized dilution/additives. |
| Physical / other chemical | Stones, metal, glass, hard plastic; cleaning residues, food-contact suitability, adulteration for economic gain, and radiological/source-specific concerns where warranted. |
8. Specifications, testing, and COA review
The QI shall approve a controlled analytical specification and sampling plan before commercial release. It shall state each analyte, acceptance limit, unit, method, sampling unit size, number/location of increments, lot definition, composite rules, detection/quantitation limits, laboratory, and frequency. A result of “ND” is meaningful only with its method and test portion.
Testing program adopted as company policy
Review a manufacturer lot-specific COA for every production lot shipped. The approved core microbiological panel and identity/quality checks shall be linked to that lot; one generic certificate shall not clear multiple unrelated lots.
Obtain independent confirmatory microbiological testing at initial qualification and at least annually thereafter, plus after a material process change or significant adverse finding. Use an appropriate laboratory, preferably ISO/IEC 17025 accredited for the relevant methods and matrix.
Obtain a pesticide and heavy-metal panel at initial qualification, for each new crop/source program, and at least annually. The QI may require lot-specific testing or a higher frequency based on risk, results, or contract requirements; record which lots the evidence supports.
Where the executed purchasing specification requires stricter testing or every-shipment testing, follow it. This policy does not reduce existing contractual testing requirements.
Parameters requiring a signed specification
Prior requested targets include aerobic plate count below 100,000 CFU/g and coliforms below 100 CFU/g, with non-detection requests for E. coli, S. aureus, Salmonella, and Listeria. These are historical purchasing targets, not verified results, finalized methods, or universal FDA garlic limits. The QI shall confirm organism identity, units, test portions, and sampling acceptance criteria before use.
Set dry matter and added-water requirements from the agreed formulation. For pesticides, assess U.S. tolerances or exemptions applicable to garlic and processed food; do not accept a generic “EU compliant” or “pesticide free” statement. Heavy-metal limits shall specify analytes, units, applicable U.S. basis, and customer requirements; do not invent a universal FDA garlic threshold. [R5]
Review and disposition
Match factory, product, lot, dates, methods, laboratory identity, and results to the shipment. Check authenticity and unclear or inconsistent data. Record the reviewer, date, pass/hold decision, and evidence. Pathogen detection, a prohibited residue, or an unresolved safety deviation triggers hold and investigation. Do not use repeated negative retests to erase a positive finding without a scientifically justified investigation and disposition.
9. Import, cold chain, and shipment release
Before shipment authorization
The QI shall complete the shipment release record using the approved factory, current specification, eligible FSVP pathway, valid supplier assurance, applicable COAs/test evidence, and closed critical deviations. Inspect invoice and packing-list consistency, lot/case quantities, production and expiry dates, ingredient/use statements, and container loading instructions. Keep the authorization separate from the later receiving release.
Entry identity
For each food line entry, ensure the importer name, email, and FDA-acceptable unique facility identifier are supplied electronically to CBP. Use Don Il Chang DBA GarlicPuree.com and Don@GarlicPuree.com with the verified identifier and matching business details. The owner-provided D-U-N-S is 118880823; confirm its entity/address match and current FDA acceptance before use. Keep broker instructions and entry records. [R1: § 1.509]
T Customs Broker handles assigned customs filings and ACC handles assigned freight functions under the existing arrangements. Confirm task ownership for prior notice and other required shipment documents. Broker processing, phytosanitary documentation, and customs/FDA release do not constitute the importer’s internal food safety release.
Frozen transport and receiving
Specify frozen handling at −18°C or colder, suitable sanitary equipment, intact seals, and temperature recording. Keep the container/seal and logger identifiers with the shipment.
At receipt, obtain the receiver’s lot/case count, package/seal condition, temperature observations, evidence of thawing or refreezing, and temperature history. Identify damaged, short, mixed, or untraceable stock.
Hold deviations pending QI review of actual time/temperature exposure, product condition, packaging, hazards, and applicable specification. A brief reefer-air excursion is not automatically a product failure; an acceptable arrival reading does not prove an acceptable transit history.
Do not release a potentially unsafe lot by refreezing it, blending it into good stock, or relying solely on smell, appearance, or a passing retest.
Release requires a signed QI decision and confirmation that any regulatory hold is resolved. If product is delivered directly to a customer, arrange receiving checks and a hold/no-use instruction until the necessary acceptance review is complete. Record who has custody and who can prevent use.
10. Traceability, corrective action, and records
Traceability and complaints
Maintain a link from Manufacturing Company’s manufacturing lot through Contracted Exporter’s documents, container/entry, warehouse pallet IDs, quantities, and every customer shipment. Preserve the original factory lot; any internal code must map back to it. Reconcile received, distributed, held, returned, and destroyed quantities. Perform a documented annual mock trace/recall as a company requirement.
Record complaints and immediately escalate illness reports, pathogen findings, chemical failures, adulteration, allergen errors, temperature abuse, or missing traceability. Notify affected custodians to stop distribution/use when warranted.
Corrective action procedure
The QI shall promptly contain affected stock, assess the scope and potentially related lots, investigate the cause, obtain supplier corrective action, determine disposition, and verify effectiveness before restoring approval. Suspend the factory when adequate assurance is lost. Record each action, date, evidence, responsible party, and closure decision. [R1: § 1.512(b)(4)]
Assess recall and regulatory notification obligations promptly, including whether any responsible party has a Reportable Food Registry duty. Do not delay an urgent protective action while waiting for a supplier response. Complete the applicable reporting assessment under a separate incident/recall procedure; this policy does not certify exemption from other laws.
Record control and FDA access
Keep original records, true copies, or electronic records, legible and protected against loss. Sign/date FSVP records at initial completion and modification. Retain original versions and an identifiable revision history. Keep accessible backups; reference existing documents rather than duplicating them unnecessarily. [R1: § 1.512(b)(5)]
| Record class | Retention rule |
|---|---|
| Required FSVP records | At least 2 years after creation or receipt under the modified pathway. |
| Very small importer support | At least 3 years as required by § 1.512(b)(5)(iii)(C); company practice: keep 3 years after the last eligibility determination relying on the record. |
| Policy / qualification / specifications | Company practice: retain while active and at least 2 years after supersession or discontinuation. |
| Lot and distribution records | Company practice: retain through the later of the regulatory minimum or 2 years after lot expiry; longer where another obligation or incident hold applies. |
Provide records promptly to FDA. Retrieve offsite records onsite within 24 hours of an official request. Provide English translations within a reasonable time if requested. When FDA requests records in writing for submission, transmit them promptly rather than requiring an onsite visit. [R1]
11. Program calendar and adoption record
| Activity | Due / trigger | Basis |
|---|---|---|
| Eligibility determination | Before first modified-pathway import; annually by December 31 | FSVP |
| Foreign supplier assurance | Before import; at least every 2 years; new site before import | FSVP / company |
| Factory / certificate / compliance review | Initial approval; annually; adverse event or change | Company |
| COA and shipment review | Every production lot / shipment | Company |
| Independent micro confirmation | Initial; annually; adverse event or material change | Company |
| Chemical panel | Initial; each new crop/source; annually; increased if risk/contract requires | Company |
| Trace exercise / policy review | Annually; sooner after change or incident | Company |
| FSVP entry identity | Each food line entry | FSVP |
Complete or reference before operational adoption
These are evidence reconciliation items, not a finding that existing work has not been done. Attach existing valid records wherever available; do not recreate completed work unnecessarily.
Signed eligibility worksheet with the correct financial scope, affiliate assessment, lookback calculation, and supporting records.
QI qualification evidence, verified importer identity/address, backup responsibilities, and signed policy approval.
Exact Manufacturing Company site identity, current certificate and audit review, executed manufacturer-change agreement, and signed supplier assurance.
One approved product specification resolving added water, case weight, ingredient statement, shelf life, and intended use.
Approved analytical limits and sampling plan, actual reports, and the recorded QI assessment of adequacy.
Shipment/receiving hold and release arrangements with the broker, forwarder, warehouse, and direct-delivery customers.
Adoption decision: __________________
Open-item register: __________________
Owner/QI signature: __________________ Date: __________________
Revision history: Rev. 1.0, 09/08/2026: initial master policy drafted for the stated very small importer operating model. Future revisions shall identify changed sections, reason, reviewer, approval, and effective date.
Appendix A. Annual eligibility worksheet
Record ID: GP-FSVP-F01 | Complete before first use and annually. [R1; R2]
Applicable calendar year: 2026 Determination date: 09/08/2026
Legal importer: Don Il Chang DBA GarlicPuree.com
Operating start date: 09/2026 Prior determination reference: 2022-2025
Financial calculations, historical sales and market-value figures, projections, valuation methods, and subsidiary or affiliate assessments are retained in controlled internal eligibility records. This information is available promptly to authorized FDA representatives upon request and is not published in this public copy.
Decision: Eligible / Not eligible / Further review required
Reason and any unresolved question: _______________________________
Next review deadline: 09/2027
I have reviewed the calculation and supporting records, including the legal-entity and affiliate scope. The selected FSVP pathway is supported by the documented facts as of this determination.
Printed name / role: DON IL CHANG / OWNER
Signature: DON IL CHANG Date: 09/08/2026
If not eligible or not adequately documented
Record the alternate pathway and the required implementation action before affected imports. Use a credible startup projection only in the circumstances described in FDA guidance, Question L.9. Net profit or one shipment’s value is not the eligibility measure.
Appendix B. Foreign supplier written assurance
Record ID: GP-FSVP-F02 | Supplier execution required. [R1: § 1.512(b)(3)(i)]
To: Don Il Chang DBA GarlicPuree.com
Foreign supplier legal name: [Legal name retained in controlled supplier records]
Manufacturing site address: _______________________________________
________________________________________________________________
Product: Frozen IQF garlic puree, approximately 20 g portions
Product specification number / revision: ____________________________
Country of manufacture: China
Exporter / seller: Contracted Exporter
Required assurance
The undersigned, acting as an authorized representative of the foreign supplier identified above, provides written assurance that this supplier is producing the identified food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or section 419 of the Federal Food, Drug, and Cosmetic Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with section 402 and section 403(w), if applicable, of that Act.
Additional company commitments
The supplier agrees to maintain the specified product identity and lot traceability, provide supporting documentation on request, and promptly notify GarlicPuree.com of a food safety event, relevant regulatory action, test failure, or material discrepancy affecting the supplied food. Proposed changes to manufacturing site, formulation, process, or specification shall be submitted for review before affected shipment.
Supplier authorized official: ______________________________________
Title: __________________________ Email: _________________________
Signature: ______________________ Effective date: _________________
Importer review
Factory and food scope match verified: YES
Signer authority / authenticity checked: YES
Supporting documents / clarifications: YES
Assurance accepted / returned for correction: ________________________
Next assurance due, no later than 2 years: ANNUALLY, 09/2027
QI printed name: DON IL CHANG
QI signature: DON IL CHANG Date: 09/08/2026
Keep this assurance separate from the COA. Update for a new foreign supplier/site before import. A completed assurance does not remove the obligation to act on contrary safety information.
Appendix C. Shipment review and release record
Record ID: GP-FSVP-F03 | One record per shipment; attach a lot schedule.
PO / shipment / container: ________________________________________
Manufacturer / site: ______________________________________________
Supplier / specification revision: __________________________________
Entry number / destination / receiver: ______________________________
Factory lot(s), production dates, expiry, and case quantities: ____________
________________________________________________________________
| Check | Evidence / result / reviewer initials |
|---|---|
| Eligible pathway; current supplier assurance | ________________________________________ |
| Approved actual factory; current specification | ________________________________________ |
| All lot COAs; required chemical/micro evidence | ________________________________________ |
| Ingredient, allergen, use, lot and date labels | ________________________________________ |
| Case/pallet quantity and weight reconciliation | ________________________________________ |
| Invoice / packing list / entry identity | ________________________________________ |
| Frozen transport and receiver hold instructions | ________________________________________ |
| Open deviations / corrective actions | ________________________________________ |
| Receipt condition, seal, logger / temperatures | ________________________________________ |
| Regulatory holds resolved; traceability complete | ________________________________________ |
Pre-shipment decision: Authorize / Hold
QI signature: _________________________ Date/time: ________________
Receipt review / temperature excursion assessment reference: __________
________________________________________________________________
Final decision: Release / Hold / Reject / Other approved disposition
Reason / conditions / affected quantity: ______________________________
________________________________________________________________
QI signature: _________________________ Date/time: ________________
Warehouse/customer notified by: ______________ Date/time: __________
Acknowledgment / distribution record reference: ______________________
Appendix D. Corrective action and approval record
Record ID: GP-FSVP-F04 | Use for supplier, laboratory, shipment, or customer findings.
Incident / deviation number: __________ Date detected: _______________
Detected by / source: _____________________________________________
Manufacturer / product / lots / quantities: ____________________________
Related shipments / customers: ____________________________________
Containment and scope
Describe the issue and evidence: ___________________________________
________________________________________________________________
Stock held, stop-use/distribution notices, and acknowledgments: _________
________________________________________________________________
Related-lot assessment and traceability reconciliation: _________________
________________________________________________________________
Investigation and disposition
Root cause / supplier response / report reference: ____________________
________________________________________________________________
Recall / reporting assessment and responsible person: _________________
________________________________________________________________
Disposition, technical justification, and authorization: __________________
________________________________________________________________
Correction and effectiveness
Corrective measures / owner / due date: ____________________________
________________________________________________________________
Effectiveness evidence and follow-up review: _________________________
________________________________________________________________
Factory status: Approved / Pending / Suspended / Rejected
FSVP / specification / verification changes required: ___________________
Closed by QI: _________________________ Date: ____________________
Reinstatement conditions, if any: ___________________________________
A corrective action is not closed merely because the supplier promises to improve. Verify the action and record why the remaining evidence supports the disposition and supplier decision.
References and controlled-record index
Regulatory review date: 09/08/2026. Regulations are binding; FDA guidance explains agency thinking and is nonbinding unless citing an applicable legal requirement. Company controls are identified separately. Source links below support the policy framework, not a finding that Manufacturing Company or a particular shipment complies.
R1. 21 CFR Part 1, Subpart L — FSVP
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-L
Definitions, applicable pathway, qualified individuals, entry identification, written assurance, corrective action, records, and full-pathway contingency.
R2. FDA — FSMA Inflation Adjusted Cut Offs
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-inflation-adjusted-cut-offs
Use the Foreign Supplier Verification Programs human-food table and retain the annual version used.
R3. FDA — FSVP Guidance for Industry, January 2023
https://www.fda.gov/media/118241/download
Nonbinding guidance, especially sections B, C, G, I, and L; consult alongside current regulations.
R4. FDA — Bad Bug Book, Second Edition
https://www.fda.gov/media/83271/download
Scientific background on pathogens and toxins. Not a garlic process validation or completed hazard analysis.
R5. 40 CFR Part 180 — Pesticide Tolerances and Exemptions
https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180
Determine applicable pesticide/commodity tolerance or exemption; evaluate the actual analytes and processed product.
Binder / electronic index
| Folder | Controlled contents |
|---|---|
| 01 Governance | Policy, revisions, signed approvals, QI qualifications, contacts. |
| 02 Eligibility | Annual worksheets, financial support, affiliate review, FDA cutoff. |
| 03 Factory | Identity, audit/certificate, approval, assurance, change agreement. |
| 04 Product | Signed specification, formulation, process, risk review, testing plan. |
| 05 Shipments | Lot reports, release records, entries, temperatures, distribution. |
| 06 Events | Complaints, corrective actions, holds, recalls, effectiveness checks. |
Completed records, signed contracts, and original laboratory reports govern factual determinations. Prior marketing drafts, supplier claims, and historical targets shall not be treated as completed verification evidence.
GP-FSVP-001 • Rev. 1.0 • Final — Approved and Adopted | Page