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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

Program Value

  • • Ensures full compliance with FDA written assurance requirements
  • • Strengthens legal and regulatory defensibility in supply chain relationships
  • • Improves traceability of responsibility for hazard control
  • • Reduces risk of non-compliance during inspections
  • • Supports scalable and structured documentation across multiple partners

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