Supply-Chain Program Compliance Management for Receiving Facilities
Regulatory Alignment with 21 CFR Part 117, Subpart G
To ensure compliance with FDA’s requirements under 21 CFR 117 Subpart G, this service supports food manufacturers, processors, and importers in establishing and maintaining a risk-based supply-chain program for raw materials and ingredients that require supply-chain-applied controls.
Our program includes development, documentation, and implementation support aligned with FDA inspection readiness and FSMA enforcement standards.
Deliverables
1. Written Supply-Chain Program
- • Development of a customized written program for raw materials and ingredients
- • Inclusion of supplier performance review criteria and risk-based control procedures
2. Supplier Approval & Documentation
- • Assessment and documentation of supplier eligibility (including qualified facilities, farms, or egg producers with exemptions)
- • Customized supplier approval forms and declarations
- • Annual re-evaluation documentation and templates
3. Supplier Verification Activity Management
- • Determination of appropriate verification activities (audit, testing, document review)
- • Calendar and frequency planning based on risk assessment and regulatory obligations
4. Onsite Audit Coordination & Support
- • Identification of when onsite audits are required (e.g., SAHCODHA-level risks)
- • Provision or coordination of audits by qualified auditors
- • Audit checklist and corrective action form templates
5. Third-Party Assurance Review
- • Review and assessment of documents provided by other entities in the distribution chain
- • Verification documentation when controls are applied by a non-supplier entity
6. Alternative Verification Options (Qualified Facilities, Farms, Shell Egg Producers)
- • Written assurance templates for exemptions
- • Recordkeeping logs and compliance reminders for annual and biennial requirements
7. Recordkeeping & Compliance Dashboard Setup
- • Creation of a records archive structure compliant with Subpart F
- • Dashboard setup for tracking supplier documentation, verification dates, and non-conformance actions
Fees and Subscriptions
Service Fee Structure
| Package | Description | One-Time Set-Up | Monthly Maintenance |
|---|---|---|---|
| Standard | Up to 5 suppliers and one production category | $1,900 | $950/month |
| Professional | Up to 15 suppliers and up to 3 production categories | $3,200 | $1,500/month |
| Enterprise | Unlimited suppliers and multiple categories | Custom Quote | Custom Quote |
Each plan includes document templates, compliance dashboard access, monthly support, and update services.
Ideal For:
- • Food manufacturers or co-packers handling high-risk ingredients
- • U.S. importers under FSVP who manage multiple suppliers
- • Facilities that outsource supplier verification to a compliance partner
- • Businesses preparing for FDA inspections or third-party certification audits