Preventive Controls & Adulteration Risk Compliance Program
Comprehensive Compliance Support under 21 CFR §117.1 & Related FSMA Provisions
To help FDA-regulated facilities prevent adulteration and maintain full compliance with FSMA mandates, especially those under 21 CFR §117.1, through tailored food safety planning, sanitary practices, and PCQI-led program oversight—spanning multiple product categories.
Scope of Work
Initial Program Setup :
✔ Applicability Assessment under 21 CFR §117.1, including exemption analysis
✔ Adulteration Risk Evaluation under FD&C Sections 402(a)(3), 402(a)(4), and 301(uu)
✔ CGMP Compliance Gap Audit (Subpart B)
✔ Development of Food Safety Plans (Subpart C & G), including:
• Ready-to-eat foods
• Dairy and refrigerated products
• Bakery and dry goods
• Dietary supplements (overlap with 21 CFR 111)
• Animal food (under 21 CFR 507)
• Beverages and low-acid canned foods
✔ PCQI Designation and Initial Training
✔ SOP Development for Monitoring, Corrective Actions, and Verification
✔ Inspection Readiness Preparation
✔ Recordkeeping Infrastructure Setup (Subpart F)
✔ Certificate of Implementation & Compliance Letter
✔ Adulteration Risk Evaluation under FD&C Sections 402(a)(3), 402(a)(4), and 301(uu)
✔ CGMP Compliance Gap Audit (Subpart B)
✔ Development of Food Safety Plans (Subpart C & G), including:
• Ready-to-eat foods
• Dairy and refrigerated products
• Bakery and dry goods
• Dietary supplements (overlap with 21 CFR 111)
• Animal food (under 21 CFR 507)
• Beverages and low-acid canned foods
✔ PCQI Designation and Initial Training
✔ SOP Development for Monitoring, Corrective Actions, and Verification
✔ Inspection Readiness Preparation
✔ Recordkeeping Infrastructure Setup (Subpart F)
✔ Certificate of Implementation & Compliance Letter
Ongoing Monthly Maintenance Services:
✔ PCQI Oversight and Monthly Record Reviews
✔ Support for FDA Audit Responses or 3rd-Party Inspections
✔ Monitoring of Multiple Food Safety Plans and Product Lines
✔ Quarterly Internal Compliance Checks
✔ Monthly Corrective Action and Verification Tracking
✔ Regulatory SOP Updates & Advisory on New Rules
✔ Documentation Review for 1–3 Suppliers per month
✔ Priority Support for Recalls or Crisis Management
✔ Support for FDA Audit Responses or 3rd-Party Inspections
✔ Monitoring of Multiple Food Safety Plans and Product Lines
✔ Quarterly Internal Compliance Checks
✔ Monthly Corrective Action and Verification Tracking
✔ Regulatory SOP Updates & Advisory on New Rules
✔ Documentation Review for 1–3 Suppliers per month
✔ Priority Support for Recalls or Crisis Management
Deliverables
• Facility-Specific Risk & Applicability Report
• CGMP Compliance Checklist
• Multi-Category Food Safety Plans (as applicable)
• SOP Set for Production, Monitoring, Verification
• Compliance Recordkeeping Framework
• Certificate of Program Completion
• Ongoing Monthly Audit Reports & Corrective Logs
• Quarterly Compliance Briefing
• CGMP Compliance Checklist
• Multi-Category Food Safety Plans (as applicable)
• SOP Set for Production, Monitoring, Verification
• Compliance Recordkeeping Framework
• Certificate of Program Completion
• Ongoing Monthly Audit Reports & Corrective Logs
• Quarterly Compliance Briefing
Ideal For:
• Manufacturers handling multiple product types or production zones
• Contract manufacturers and co-packers
• Supplement or animal food producers needing hybrid compliance (21 CFR 111 + 117 + 507)
• U.S. and foreign food facilities seeking long-term PCQI and inspection readiness support
• Contract manufacturers and co-packers
• Supplement or animal food producers needing hybrid compliance (21 CFR 111 + 117 + 507)
• U.S. and foreign food facilities seeking long-term PCQI and inspection readiness support
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.