Annual FSVP Maintenance Package
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For U.S. importers 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
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- • Centralized, audit-ready records (no missing or outdated files).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
• Annual Compliance Summary Report (key updates, action items, regulatory alignment).
• Updated FSVP Documents & Risk Assessment (FDA-ready formats).
• Version-Controlled Master Files (organized for traceability).
Fees and Subscriptions
Annual Maintenance Package – $2,400 USD/year
Related Compliance Integration (Optional Add-Ons)
- • Food Defense / IA Rule Updates (21 CFR 121) – *$500/year* • Recall Plan Effectiveness Check (21 CFR 117.139) – *$300/year*
Ideal For:
- ✔ U.S. Importers maintaining an existing FSVP.
- ✔ Brand owners, distributors, or co-packers seeking hands-off compliance.
- ✔ Businesses preparing for FDA inspections or third-party audits.