Preventive Controls & Adulteration Risk Compliance Program
Compliant with 21 CFR §117.1 & FSMA Preventive Controls Requirements
This program provides comprehensive support for identifying, preventing, and managing adulteration risks while ensuring compliance with 21 CFR §117.1 and related FSMA provisions, integrating hazard analysis, CGMP compliance, preventive controls, and PCQI oversight to establish a fully compliant and audit-ready food safety system for multi-product and complex operations under the Food Safety Modernization Act (FSMA).
Program Objective
To develop, implement, and maintain a structured Preventive Controls and Adulteration Risk Management System that:
• Identifies and mitigates risks of adulteration (intentional and unintentional)
• Ensures compliance with FSMA Preventive Controls requirements
• Establishes CGMP-aligned operational controls
• Supports multi-category food safety plan development and management
• Maintains audit-ready documentation and continuous PCQI oversight
• Ensures compliance with FSMA Preventive Controls requirements
• Establishes CGMP-aligned operational controls
• Supports multi-category food safety plan development and management
• Maintains audit-ready documentation and continuous PCQI oversight
Scope of Work
Applicability & Regulatory Assessment
• Applicability determination under FSMA, including exemption analysis
• Evaluation of adulteration risks in alignment with:
◦ FD&C Act Section 402(a)(3)
◦ FD&C Act Section 402(a)(4)
◦ FD&C Act Section 301(uu)
• Evaluation of adulteration risks in alignment with:
◦ FD&C Act Section 402(a)(3)
◦ FD&C Act Section 402(a)(4)
◦ FD&C Act Section 301(uu)
CGMP Compliance & Gap Analysis (Subpart B)
• Comprehensive CGMP audit to identify compliance gaps
• Evaluation of sanitation, personnel practices, and facility conditions
• Recommendations for corrective actions and system improvements
• Evaluation of sanitation, personnel practices, and facility conditions
• Recommendations for corrective actions and system improvements
Food Safety Plan Development (Subparts C & G)
Development and management of Food Safety Plans across multiple product categories, including:
• Ready-to-eat (RTE) foods
• Dairy and refrigerated products
• Bakery and dry goods
• Dietary supplements (aligned with 21 CFR Part 111 where applicable)
• Animal food (aligned with 21 CFR Part 507)
• Beverages and low-acid canned foods
Each plan includes hazard analysis, preventive controls, monitoring, corrective actions, verification, recall planning, and supply-chain program integration
• Ready-to-eat (RTE) foods
• Dairy and refrigerated products
• Bakery and dry goods
• Dietary supplements (aligned with 21 CFR Part 111 where applicable)
• Animal food (aligned with 21 CFR Part 507)
• Beverages and low-acid canned foods
Each plan includes hazard analysis, preventive controls, monitoring, corrective actions, verification, recall planning, and supply-chain program integration
PCQI Designation & Training
• Assignment or support of a Preventive Controls Qualified Individual (PCQI)
• Initial training and qualification documentation
• Ongoing oversight of Food Safety Plan implementation and verification
• Initial training and qualification documentation
• Ongoing oversight of Food Safety Plan implementation and verification
SOP Development & Compliance Systems
• Development of Standard Operating Procedures (SOPs) covering:
◦ Monitoring procedures
◦ Corrective actions
◦ Verification activities
• Alignment with regulatory requirements and operational practices
◦ Monitoring procedures
◦ Corrective actions
◦ Verification activities
• Alignment with regulatory requirements and operational practices
Inspection Readiness & Recordkeeping (Subpart F)
• Preparation for FDA inspections and third-party audits
• Development of structured recordkeeping systems • Implementation of compliant documentation practices and audit trails
• Development of structured recordkeeping systems • Implementation of compliant documentation practices and audit trails
Ongoing Program Support
• Monthly PCQI oversight and record review
• Support for FDA inspections and third-party audit responses
• Monitoring of multiple Food Safety Plans and product categories
• Quarterly internal compliance assessments
• Continuous corrective action and verification tracking
• Regulatory updates and SOP revisions based on new requirements
• Supplier documentation review and compliance monitoring
• Priority support for recalls, incidents, or crisis events
• Support for FDA inspections and third-party audit responses
• Monitoring of multiple Food Safety Plans and product categories
• Quarterly internal compliance assessments
• Continuous corrective action and verification tracking
• Regulatory updates and SOP revisions based on new requirements
• Supplier documentation review and compliance monitoring
• Priority support for recalls, incidents, or crisis events
Deliverables
• Facility-specific applicability and adulteration risk assessment report
• CGMP compliance checklist and gap analysis report
• Multi-category Food Safety Plans (as applicable)
• SOPs for monitoring, corrective actions, and verification
• Structured compliance recordkeeping system
• Certificate of program implementation and compliance
• Ongoing audit reports and corrective action logs
• Quarterly compliance summary and risk briefing
• CGMP compliance checklist and gap analysis report
• Multi-category Food Safety Plans (as applicable)
• SOPs for monitoring, corrective actions, and verification
• Structured compliance recordkeeping system
• Certificate of program implementation and compliance
• Ongoing audit reports and corrective action logs
• Quarterly compliance summary and risk briefing
Ideal For
• Manufacturers handling multiple product types or production environments
• Contract manufacturers and co-packers
• Dietary supplement and animal food producers requiring hybrid regulatory compliance (21 CFR 111, 117, and 507)
• U.S. and foreign food facilities seeking long-term PCQI oversight and inspection readiness
• Operations requiring integrated adulteration risk management and preventive controls systems
• Contract manufacturers and co-packers
• Dietary supplement and animal food producers requiring hybrid regulatory compliance (21 CFR 111, 117, and 507)
• U.S. and foreign food facilities seeking long-term PCQI oversight and inspection readiness
• Operations requiring integrated adulteration risk management and preventive controls systems
Program Value
• Ensures comprehensive FSMA compliance across multiple product categories
• Reduces risk of adulteration through structured hazard and control systems
• Strengthens audit readiness and regulatory defensibility
• Provides centralized oversight through PCQI-led compliance management
• Supports scalable compliance for growing and complex operations
• Reduces risk of adulteration through structured hazard and control systems
• Strengthens audit readiness and regulatory defensibility
• Provides centralized oversight through PCQI-led compliance management
• Supports scalable compliance for growing and complex operations
Fees and Subscriptions
Pricing Structure:
| Service Tier | One-Time Setup Fee | Monthly Maintenance Fee | Included Categories |
|---|---|---|---|
| Standard | $1,900 | $950/month | 1 food safety plan (single category) |
| Enhanced | $3,200 | $1,900/month | Up to 2 food safety plans (e.g., bakery + dairy) |
| Premium | $4,800 | $2,750/month | Up to 4 food safety plans + mock audit, annual review |
| Enterprise | Custom Quote | Custom Quote | 5+ food categories or multiple facilities/brands |
Add-on Fee for Each Additional Food Safety Plan (beyond included): $750 (one-time)
Volume discounts available for multi-site clients or corporate accounts.
Volume discounts available for multi-site clients or corporate accounts.
