Stay Compliant with Written Assurance Management: What Importers and Manufacturers Need to Know
When it comes to FDA compliance—especially under the Foreign Supplier Verification Program (FSVP) and 21 CFR Part 117—one critical but often overlooked requirement is the management of written assurance agreements. These documents serve as formal confirmations that contract manufacturers, co-manufacturers, and suppliers are taking responsibility for specific supply-chain-applied controls designed to prevent food safety hazards.
Written Assurance Management: A Regulatory Must-Have
Draft and maintain written assurance agreements with contract manufacturers, co-manufacturers, and suppliers to confirm the implementation of supply-chain-applied controls. This is required under 21 CFR 117.335 and must be updated for each new agreement or annually. These records are a key part of your compliance program and essential to proving that food safety responsibilities are clearly assigned throughout your supply chain.
What Is Written Assurance?
A written assurance is a signed statement from a supply chain partner acknowledging their role in implementing preventive controls—such as allergen management, sanitation, or foreign material prevention. If you're relying on another party to manage these controls, the FDA expects this to be documented formally.
What Should It Include?
To meet FDA expectations, each written assurance must contain:
- • A clear description of the preventive control(s) being applied
- • A statement of responsibility from the supplier or co-manufacturer
- • Details of any monitoring, verification, or corrective action procedures
- • Authorized signatures and date
- • An update clause in case of operational changes
Review Frequency: Annual or Per Contract
• New Agreements: A new written assurance must be executed whenever a new supplier or co-manufacturer is added to the supply chain.
• Annual Updates: All existing written assurances must be reviewed and renewed at least annually to ensure accuracy and relevance.
Failing to maintain or update these documents can result in regulatory citations, import delays, or even product recalls during inspections.
Use InterlinkIQ.com to Streamline Compliance
Managing assurance documentation manually can expose your business to risk. That’s why FSVPServices.com integrates the power of InterlinkIQ.com — a robust compliance management system software designed to automate and streamline documentation control.
With InterlinkIQ, you can:
- • Digitally manage all written assurance records with version control
- • Set automated reminders for annual renewals or new agreements
- • Track changes and user access for full traceability
- • Store and organize documents in a secure, audit-ready platform
- • Generate reports for supplier oversight, FDA audits, or internal reviews
How FSVPServices.com Can Help
At FSVPServices.com, we simplify your compliance process by:
- • Drafting FDA-compliant written assurance agreements
- • Customizing templates for your contract manufacturers and suppliers
- • Managing updates using InterlinkIQ’s automated workflows
- • Offering full integration of your assurance management into a secure compliance system
Take Action Today
Don’t let missing or outdated written assurances jeopardize your compliance.
Partner with FSVPServices.com and InterlinkIQ.com to automate, manage, and protect your entire supply-chain documentation system.
📩 Contact US or Visit InterlinkIQ.com to learn more or book your compliance review today.