Navigate FSMA Preventive Controls with a Certified Food Safety & Quality Auditor. From hazard analysis to supply chain verification, we build food safety systems that pass FDA inspections and third-party audits.
Jared Clark, JD, MBA, CFSQA, CPGP, RAC -- one of the few GMP consultants certified across food safety, pharmaceutical GMP, and regulatory affairs.
21 CFR Part 117 is the FDA regulation that governs current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. It is the backbone of the Food Safety Modernization Act (FSMA) and applies to nearly every food facility in the United States.
Unlike the older approach that relied on reacting to contamination after it happened, FSMA shifted FDA's framework to prevention. Under Part 117, food manufacturers must proactively identify hazards, implement controls to prevent them, monitor those controls, and verify the entire system is working. The regulation has three core components:
Baseline requirements for personnel, buildings, equipment, production, warehousing, and distribution. These are the foundational hygiene and facility controls that every food manufacturer must meet -- regardless of size or product type.
Requires a written food safety plan with hazard analysis, preventive controls for identified hazards (process, allergen, sanitation, supply chain), monitoring procedures, corrective actions, and verification activities. A Preventive Controls Qualified Individual (PCQI) must oversee the plan.
When a hazard is controlled by your supplier rather than your own facility, you must establish a risk-based supply chain program. This includes approved supplier verification activities, onsite audits, testing, and documentation requirements.
Part 117 applies to all facilities that manufacture, process, pack, or hold human food for US sale. This includes food manufacturers and processors, co-packers, warehouses and distribution centers, importers, ingredient suppliers, bakeries, snack manufacturers, and beverage producers. Limited exemptions exist for very small businesses, farms, and facilities under other FDA rules (seafood HACCP, juice HACCP).
FDA enforcement is active. Since FSMA Preventive Controls became fully effective, FDA has issued warning letters and import alerts to facilities lacking compliant food safety plans. Non-compliance puts your ability to manufacture and distribute food at risk.
End-to-end food safety consulting -- from initial gap analysis through audit day and beyond
Complete implementation of FSMA Preventive Controls for Human Food. We develop your written food safety plan, identify and evaluate hazards, and establish process controls, allergen controls, and sanitation controls tailored to your operation.
Rigorous hazard analysis covering biological, chemical (including radiological), and physical hazards at every step of your process. We identify hazards requiring preventive controls and establish critical limits, monitoring frequencies, and corrective action procedures.
Build a compliant supply chain program under 21 CFR 117 Subpart G. We establish approved supplier lists, verification activities, and Foreign Supplier Verification Program (FSVP) procedures for imported ingredients. Ensure every ingredient entering your facility meets safety standards.
Develop your complete documentation system: standard operating procedures, sanitation schedules, pest control programs, equipment maintenance logs, recall procedures, and complaint handling protocols. Every document is written to satisfy both FDA inspectors and third-party auditors.
Build a food safety culture from the ground up. We develop training curricula for all personnel -- from line workers to quality managers. Training covers cGMP requirements, allergen awareness, personal hygiene, and your specific preventive controls. All training is documented and audit-ready.
Get audit-ready for third-party food safety certifications. We prepare your facility for SQF, BRC Global Standards, and FSSC 22000 audits -- all GFSI-benchmarked schemes that major retailers and food service companies require. Includes mock audits with detailed finding reports and FDA inspection preparation.
Every major food safety certification builds on top of GMP compliance. Without a solid cGMP foundation, third-party certifications are impossible to achieve -- or maintain.
SQF, BRC, FSSC 22000 -- the certifications that major retailers, foodservice companies, and international buyers require. These are your competitive advantage.
Hazard analysis, preventive controls, monitoring, corrective actions, verification. The written food safety plan is your legally mandated system under 21 CFR 117 Subpart C.
Personnel practices, facility design, sanitary operations, equipment maintenance, process controls, warehousing, and distribution. This is the non-negotiable baseline.
Many food manufacturers try to jump straight to a GFSI certification like SQF or BRC without first establishing robust cGMP practices. This approach fails. Third-party auditors assess your GMP foundation as part of every certification audit. If your facility lacks proper sanitation programs, equipment maintenance, or personnel hygiene practices, you will not pass -- regardless of how polished your food safety plan looks on paper.
We build your compliance from the ground up. Starting with cGMP fundamentals in 21 CFR 117 Subpart B, then layering on your food safety plan with preventive controls, and finally preparing you for whichever GFSI-benchmarked certification your customers require. This layered approach is why our clients achieve certification on the first attempt.
Most food safety consultants only know food. Jared Clark consults across dietary supplements, pharmaceutical and OTC drug manufacturing, cosmetics, and food. This cross-industry perspective creates tangible advantages for food manufacturers.
Pharmaceutical GMP (21 CFR 210/211) is among the most rigorous quality frameworks in the world. When you work with a consultant who understands pharma-grade quality systems, you benefit from that rigor applied to your food operation. The result is documentation, training, and process controls that exceed what food-only consultants deliver.
SOPs, batch records, and quality procedures built to pharmaceutical standards -- far exceeding what most food auditors expect. Your documentation becomes a competitive asset.
Experience with pharmaceutical cleanroom controls and supplement allergen programs translates directly to food allergen management and sanitation validation.
A JD and RAC certification mean we understand the legal and regulatory context behind FDA food safety rules -- not just the letter of the regulation, but the enforcement trends and inspection priorities.
Certified Food Safety & Quality Auditor
ASQ
Certified Pharmaceutical GMP Professional
ASQ
Regulatory Affairs Certification
RAPS
Juris Doctor
Law Degree
Certified Manager of Quality
ASQ
Master of Business Administration
Business
Schedule a free consultation with Jared Clark, CFSQA, CPGP, RAC. We will assess your current 21 CFR Part 117 compliance, identify gaps in your food safety plan, and map a clear path to FDA and third-party audit readiness.