Written Assurance Compliance Management Program
FDA-Compliant Written Assurance Development & Oversight Program Supply Chain Legal Documentation Support per 21 CFR §117.335
To assist food manufacturers, processors, and importers in meeting the FDA’s written assurance documentation requirements under §117.136(a)(2)-(4) and §117.430(c)-(e). This program ensures that any delegation of hazard control to downstream customers or suppliers is supported by valid, signed documentation that meets FDA expectations and withstands inspection or enforcement review.
Scope of Work
Initial Setup (One-Time Fee):
1. Written Assurance Template Development – §117.335(a)
Prepare legally compliant templates that include:
- • Effective date
- • Printed names and authorized signatures
- • Assurance language tailored to the applicable clause under §§117.136 or 117.430
2. Legal Responsibility & Termination Clause – §117.335(b)
- • Draft language to clarify responsibility assumption and compliance reversion upon termination
- • Review for consistency with upstream/downstream FSMA roles
3. Review of Hazard Delegation & Records Requirements – §117.136
- • Map which hazards are being controlled downstream
- • Determine the appropriate written assurance requirement (e.g., from manufacturer to customer, or from co-packer to brand owner)
- • Include required annual renewal and documentation process
4. Document Execution & Retention SOP
- • Create a compliance SOP for executing, renewing, and maintaining written assurances
- • Include timeline tracking tools and digital repository setup guidance
5. Training on Proper Use & Implementation
- • Educate compliance and operations teams on when and how to issue written assurances
- • Ensure consistent language in shipping documents and regulatory declarations
Deliverables
• Written Assurance Templates per §117.335
• Assurance Responsibility Tracker & Renewal Calendar
• SOP for Document Execution, Retention, and Termination
• Annual Assurance Review Report
• Training Module on Written Assurance Implementation
• Support for Reversion Scenarios and Delegation Mapping
• Certificate of Documentation System Implementation
Fees and Subscriptions
Ongoing Monthly Maintenance Services:
- ✔ Tracking of written assurance renewal dates and updates
- ✔ Annual review of customer/supplier written assurance records
- ✔ Advisory support during FDA inspections related to §117.335
- ✔ Coordination with downstream customers and upstream suppliers for documentation
- ✔ SOP updates and regulatory change alerts
- ✔ Support for documentation termination, responsibility reversion, and FDA notification
Pricing Structure:
| Service Tier | One-Time Setup Fee | Monthly Maintenance Fee | Coverage |
|---|---|---|---|
| Standard | $950 | $450/month | 1–2 written assurances with annual renewal support |
| Enhanced | $1,800 | $950/month | Up to 5 written assurances (mixed upstream/downstream) |
| Premium | $2,800 | $1,600/month | 6–10 written assurances + multi-party coordination |
| Enterprise | Custom Quote | Custom Quote | Multi-brand, multi-supplier chain with legal oversight & system integration |
• Add-On: Legal Review of Custom Terms – Starting at $600 per assurance
• Add-On: Digital Signature & Archiving System Setup – Starting at $750
Ideal For:
- • Co-packers, private label manufacturers, and U.S. importers relying on downstream controls
- • Suppliers delegating allergen or pathogen controls to customers
- • Facilities issuing or receiving raw materials with identified hazards
- • Companies needing structured legal documentation to pass FDA inspections or third-party audits
- • Operations with both foreign and domestic supply chain compliance obligations