FSVP QI Ongoing Verification Maintenance Services

1. Supplier-Level FSVP Verification

(Per Supplier – Minimum 1 Supplier Required)

Supplier-level verification activities are conducted in accordance with FDA FSVP requirements and maintained within the Company’s centralized FSVP recordkeeping system (interlinkIQ Supplier Module).

Activities may include:

• Collection and administrative review of supplier identification information
  (legal name, address, country of manufacture)
• FDA food facility registration confirmation
• Review of supplier preventive controls documentation, where applicable:
  • Process controls
  • Sanitation controls
  • Allergen controls
  • Supply-chain controls
• Review of applicable food safety certifications (e.g., GFSI-recognized schemes), where available
• Review of supplier food safety programs and procedures relevant to U.S. food safety compliance
• Review of supplier compliance history, including:
  • FDA warning letters
  • Import refusals
  • Inspection outcomes or enforcement actions
• Review of corrective action documentation related to identified food safety issues
• Reanalysis activities when required under 21 CFR 1.505–1.506

Deliverables (Supplier Level):

• FSVP Supplier Verification Report documenting:
  • Supplier information reviewed
  • Verification activities performed
  • Assessment outcomes and compliance status
  • Noted gaps or deficiencies (if any)
• Reanalysis documentation, when applicable

Excludes onsite audits, SOP development, and gap assessments unless separately contracted.

2. Product / Material-Level FSVP Verification

(Per SKU – Minimum 1 SKU Required)

Product-level verification is conducted for each imported SKU or material and is linked to an approved foreign supplier within the FSVP program.

Activities may include:

• Collection and review of product/SKU identification details:
  • Product name and description
  • Formulation or composition (where applicable)
• Intended use evaluation
• Country of manufacture and linkage to the approved foreign supplier
• Review of product-specific hazard analysis identifying known or reasonably foreseeable hazards
• Review of preventive controls applicable to the product or material:
  • Process controls
  • Allergen controls
  • Sanitation controls
  • Supply-chain controls (as applicable)
• Review of Certificates of Analysis (COAs) or analytical documentation supporting verification activities, where applicable
• Review of product-related food safety certifications or attestations, where available
• Review of corrective action documentation related to SKU-specific issues
• Review of change notifications impacting the SKU (e.g., formulation changes, supplier changes, process changes)

Determination of verification activity type and frequency based on risk.