Annual FSVP Maintenance Package
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For entities with an existing FSVP program, this annual service ensures continuous compliance with FDA 21 CFR 1.500–1.514 and related regulations. We proactively review, update, and organize your FSVP documentation to mitigate risks and maintain inspection readiness.
Scope of Work
- Supplier Hazard Analysis
- Review of potential hazards associated with the supplier’s processes, environment, and product categories.
- Evaluation of Food Safety Controls
- Assessment of preventive controls, sanitation programs, and risk-based mitigation strategies.
- FDA Compliance History Review
- Analysis of past compliance, inspection records, and overall regulatory performance.
- Import Alert & Warning Letter Screening
- Checking suppliers and facilities against FDA alerts, refusals, import alerts, and enforcement records.
- Certification & Regulatory Documentation Review
- Verification of third-party certifications, COAs, and other compliance documents.
- Corrective Action Evaluation
- Review of corrective actions taken in response to deviations, complaints, or audit findings.
- Verification Activity Plan & Frequency Determination
- Establishing the appropriate verification steps and required frequency based on supplier and product risk.
- Annual FSVP Reanalysis
- Conducting a yearly review of all supplier data, documentation, and hazard analyses in accordance with 21 CFR 1.505.
- Maintenance Per SKU
- Product Hazard Analysis
• Evaluation of potential biological, chemical, and physical hazards associated with each individual product, formulation, and intended use.
- Ingredient and Allergen Review
• Assessment of ingredients, allergen declarations, and cross-contact risks to ensure compliance with U.S. labeling and safety requirements.
- Product Specification Review
• Verification of product specifications, quality parameters, COAs, and related documentation to ensure accuracy and regulatory consistency.
- Risk Level Determination
• Assigning a risk category (low/medium/high) based on product type, process controls, supplier performance, and historical compliance data.
- Verification Activity Planning
• Establishing appropriate verification steps, such as COA review, batch documentation, supplier audits, or testing, and defining required frequency.
- Annual Reanalysis (if applicable)
• Reviewing and updating the product-specific hazard analysis, risk level, and verification activities annually or when new information becomes available, as required under 21 CFR 1.505.
1. Annual Review & Updates of FSVP Documents
- • Comprehensive audit of FSVP records for regulatory accuracy and operational relevance.
- • Updates to reflect new suppliers, products, or FDA regulatory changes.
- • Alignment with 21 CFR 117 (Subpart G), 121, 1.1315, and other applicable rules.
2. Updated Risk Assessment Report
- • Re-evaluation of supplier risks (food safety history, audit results, recalls).
- • Revised risk categorizations with FDA-compliant justifications.
- • Mitigation strategies for high-risk suppliers.
3. Version Control & Documentation Review
- • Tracked revisions with timestamps, change logs, and responsible parties.
- • Centralized, audit-ready records (no missing or outdated files).
- • Compliance with 21 CFR 117.315 (record retention).
Deliverables
Fees and Subscriptions
$540/year per supplier, plus maintenance for FSVP products (starts at $270/year per SKU)
Related Compliance Integration (Optional Add-Ons)
- • FSVP Onsite Support (FDA/FSIS Audit) – $1,200 per day + travel, lodging, meals
- • Certificate of Analysis (COA) / Laboratory Report Interpretation – $45 per document
- • Environmental Monitoring Review – $85 per batch
Ideal For:
- ✔ Food companies maintaining an existing FSVP
- ✔ Brand owners, distributors, or co-packers seeking hands-off compliance.
- ✔ Businesses preparing for FDA inspections or third-party audits.
