Food Safety Consulting

A Food Safety Plan That Works on Your Floor

The heart of Part 117 is a written Food Safety Plan built on hazard analysis and risk-based preventive controls, covering process, allergen, sanitation, and supply-chain controls, overseen by a Preventive Controls Qualified Individual. We develop and validate these plans with your team, so the document FDA reads matches the way your facility actually runs. For the regulation itself, see FDA's official FSMA page.

• FSMA and 21 CFR Part 117 preventive controls compliance
• Food Safety Plan, HACCP, and hazard analysis development
• Allergen, sanitation, and supply-chain control programs
• PCQI oversight support
• FDA food facility registration
• Inspection readiness and 483 response

From Registration to Inspection Day

We support FDA food facility registration, build the sanitation and allergen programs that inspections probe hardest, and prepare your team through mock audits and inspection readiness. When findings need structural fixes, our GMP remediation programs close them out, and supplier audit management covers the supply-chain controls your plan depends on. Onsite across California, remote nationwide.

Food Safety Questions

What FDA regulations apply to food manufacturing?

Food manufacturers must comply with FSMA and 21 CFR Part 117, the FDA's Current Good Manufacturing Practice and Preventive Controls for Human Food rule. It requires a written Food Safety Plan built on hazard analysis and risk-based preventive controls, overseen by a Preventive Controls Qualified Individual (PCQI).

What is a PCQI?

A Preventive Controls Qualified Individual is the person responsible for preparing and overseeing your Food Safety Plan, qualified through recognized training or job experience. We help facilities meet the PCQI requirement and build plans that hold up in FDA inspections.

Do we need HACCP or a Food Safety Plan?

For most FDA-regulated food facilities, 21 CFR Part 117 requires a Food Safety Plan with hazard analysis and preventive controls, which is broader than classic HACCP. Facilities with existing HACCP programs have a head start, and we help translate them into fully compliant Food Safety Plans.

Who has to register as a food facility with FDA?

Facilities that manufacture, process, pack, or hold food for consumption in the United States must register with FDA and renew that registration every two years. We support registration and keep you inspection-ready after it.