Food Safety Plan Reanalysis & Update Service
Compliance with 21 CFR §117.170
To maintain compliance with FDA’s preventive controls rule, this service provides comprehensive support in conducting timely reanalysis of your food safety plan in accordance with §117.170.
Scope of Work
Reanalysis Triggers & Conditions
We provide reanalysis services under the following scenarios:
- 1. Scheduled Reanalysis (Every 3 Years)
- • Full review of the food safety plan to ensure continued regulatory alignment and risk mitigation.
- • After significant changes in facility activities or processes.
- • Upon emergence of new hazard-related information.
- • Following an unanticipated food safety event or audit finding.
- • If existing preventive controls are deemed ineffective.
- • If new scientific data or regulatory updates require plan modification.
Deliverables
- • Gap assessment and risk-based analysis of current food safety plan
• Revised hazard analysis and applicable updates to preventive controls
• Validation of new or modified preventive controls
• Documentation and PCQI certification of reanalysis
• Reanalysis timeline justifications (if exceeding 90 days from trigger event)
• FDA inspection preparedness report
Fees and Subscriptions
Monthly Maintenance Support Inclusions
- • Annual review of food safety plan performance
- • Real-time tracking of regulatory updates
- • Trigger-based alerts and review initiation
- • Quarterly consultation with PCQI
- • FDA-directed reanalysis support at no additional charge
Service Fee Structure
| Plan | Description | Monthly Fee |
|---|---|---|
| Standard | Scheduled triennial reanalysis support and PCQI oversight | $950/month |
| Premium | Includes mid-cycle reanalysis, validation updates, and FDA event response | $1,600/month |
| Enterprise | Custom plan for multi-site compliance, centralized PCQI, and multi-product reanalysis | Starting at $2,500/month |
This service ensures your food safety plan stays current, validated, and defensible during inspections.