Written Assurance Compliance Management Program

Compliant with 21 CFR §117.335 — FDA Written Assurance Requirements

This program provides a structured system for developing and managing FDA-compliant written assurances when hazard control is delegated within the supply chain, ensuring all assurances are legally sound, properly executed, and audit-ready in alignment with 21 CFR §117.335, §117.136, and §117.430.

Program Objective

To establish and maintain a compliant Written Assurance Documentation System that:

• Supports lawful delegation of hazard controls across the supply chain
• Ensures all written assurances meet FDA regulatory requirements
• Provides traceable, signed, and current documentation
• Aligns supplier and customer responsibilities under FSMA
• Prepares facilities for FDA inspections and enforcement review

Scope of Work

1. Written Assurance Template Development

• Development of compliant templates including:

◦ Effective date and version control
◦ Printed names and authorized signatures
◦ Clause-specific assurance language aligned with regulatory requirements

• Customization based on supplier, customer, or co-manufacturer relationships

2. Legal Responsibility & Termination Clause

• Drafting of clauses defining responsibility for hazard control
• Documentation of responsibility transfer and reversion upon termination
• Alignment with contractual and regulatory obligations

3. Hazard Delegation & Compliance Mapping

• Identification of hazards controlled by downstream or upstream entities
• Determination of appropriate written assurance requirements
• Mapping of documentation requirements across supply chain relationships
• Integration of annual renewal and compliance tracking processes

4. Document Execution & Recordkeeping SOP

• Development of SOPs for:

◦ Execution and approval of written assurances
◦ Renewal and update processes
◦ Retention and archival of documentation

• Setup guidance for digital or centralized document repositories

5. Training & Implementation Support

• Training for compliance and operations teams on written assurance requirements
• Guidance on consistent use of assurance language in documentation and communications
• Support for proper implementation across supply chain activities

Deliverables

• Written assurance templates aligned with FDA requirements
• Responsibility tracking system and renewal calendar
• SOP for document execution, retention, and termination
• Annual written assurance review and compliance report
• Training module on written assurance implementation
• Hazard delegation mapping documentation
• Certificate of implementation for written assurance compliance system

Ongoing Program Support

• Tracking and management of written assurance renewal timelines
• Annual review of supplier and customer assurance documentation
• Advisory support during FDA inspections related to written assurances
• Coordination with supply chain partners for documentation compliance
• Updates to SOPs based on regulatory changes
• Support for termination events and responsibility reversion scenarios

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 contract processors
• U.S. importers managing supply-chain-applied controls
• Suppliers delegating allergen or pathogen control responsibilities
• Facilities handling raw materials with identified hazards
• Companies requiring structured legal documentation for FDA inspections or audits
• Operations with complex domestic and international supply chains