Preventive Controls on Paper Only
Food safety plans that don't match floor practice. Monitoring records with gaps. Corrective actions taken but never documented — so legally, they never happened.
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GMP readiness for food & beverage manufacturers.
571 food & drink recall events were recorded in 2025 — a nine-year high (Sedgwick 2026 State of the Nation Recall Index, based on FDA data). Most trace back to the same failures: weak preventive controls, unqualified suppliers, and sanitation programs with no evidence behind them. We find those gaps before an inspector — or a recall — does.
WHY NOW
The enforcement environment has changed.
Recalls are at a nine-year high, traceability rules are enforceable, and co-packers inherit every supplier's risk. The documentation burden keeps growing — the evidence has to grow with it.
571FDA food & drink recall events in 2025 — a nine-year high, driven by Listeria, Salmonella, and undeclared allergens.Source: Sedgwick 2026 State of the Nation Recall Index, based on FDA data.
21 CFR 117Preventive controls for human food: the rule most facilities live under — and the source of most 483 observations.
FSMA 204The food traceability rule is now enforceable for high-risk foods. Lot-level traceability in hours, not days.
WHERE IT BREAKS
The four failures behind most food recalls.
Same pattern, different facility. If any of these sound familiar, the gap is already priced into your risk.
Suppliers You Can't Defend
Co-packers inherit every supplier's risk. Approval files are thin, verification activities are missing, and nobody can show why a supplier was trusted.
Sanitation Without Evidence
Environmental monitoring designed to pass, not to find. Harborage sites unmapped. A Listeria program that has never found Listeria is not a good sign — it's a blind spot.
Recall Plans Never Tested
Traceability that takes days instead of hours. Mock recalls never performed. Lot genealogy that falls apart the moment a customer asks for it under pressure.
WHAT WE DO
Our method, mapped to food & beverage.
The same evidence discipline we built in cannabis — adapted to Part 117, FSMA, and the realities of shared lines and customer SKUs. And when the assessment finds gaps, we don't just hand you a report — we execute the full validation work (IQ/OQ/PQ, process validation) to close them.
GMP Readiness Assessment
Our flagship four-week engagement, baselined against 21 CFR Part 117: food safety plan execution, supplier verification, sanitation and environmental monitoring, traceability, and allergen controls.
You receive a prioritized gap register ranked by risk — and a remediation roadmap sequenced for your next inspection, audit, or customer qualification.
CQV for Food Plants
Commissioning and qualification for processing lines, CIP systems, retorts, ovens, and cold-chain equipment — IQ/OQ/PQ that reflects how the line actually runs, including changeover and allergen-clean validation.
CSV for Traceability & Lab Systems
Risk-based validation for ERP, MES, and traceability platforms, laboratory systems, and temperature-monitoring networks — requirements, testing, audit trails, alarms, and data integrity.
Quality Systems & Remediation
Supplier qualification files that hold up, environmental monitoring program design, mock-recall protocols, SOP development — and structured 483 and warning-letter response when enforcement has already arrived.
THE RULES THAT CREATE THE BURDEN
What you're actually being judged against.
Inspectors don't grade intentions. They grade records against these requirements.
21 CFR Part 117
Current good manufacturing practice, hazard analysis, and risk-based preventive controls for human food — the foundation of most FDA food inspections.
FSMA Section 204
Traceability recordkeeping for high-risk foods. If you can't trace a lot forward and back within hours, the rule is already a finding.
Allergen Controls
FALCPA plus the FASTER Act's sesame requirement: undeclared allergens remain a top recall driver. Label verification and changeover evidence are non-negotiable.
Supplier Verification
Foreign Supplier Verification and domestic supplier programs: approval, verification activities, and corrective action — documented, not assumed.
QUESTIONS
Food & beverage, answered.
We are a co-packer running dozens of customer SKUs. Can one assessment cover that?
Yes. We scope by process family and line, not by SKU count. Shared equipment, changeover controls, allergen management, and label-verification systems are assessed once per line — then we map where customer-specific requirements create additional risk.
We already have a PCQI and a food safety plan. What do you add?
We test whether the plan survives contact with the floor. Most gaps we find are not missing plans but broken execution: monitoring records with gaps, corrective actions never documented, verification activities skipped. We produce the evidence your plan claims exists.
Can you help us respond to an FDA 483 or warning letter?
Yes. We trace each observation to its root cause, build the evidence your response commits to, and sequence corrective actions so the follow-up inspection finds closures instead of repeats.
How is this different from our SQF or BRC audit preparation?
Certification audits check that a system exists. We build the underlying evidence — qualification records, validated monitoring, traceability that actually traces. Manufacturers often run an assessment like this first, then walk into their certification audit with documentation that holds up.
Do you work with small facilities or only large plants?
Both. Small and mid-size manufacturers and co-packers are our sweet spot — they face the same Part 117 obligations as large plants but rarely have a full validation bench in-house.
FREE DOWNLOAD
Get the Free Checklist
Find your gaps before an auditor does.
Our free 25-point Food & Beverage GMP Checklist — the same questions auditors ask, as a yes/no self-check. Every unchecked box is a finding waiting to happen.
Don't let the first gap be found under pressure.
Start with a free readiness call — food & beverage focused. We'll walk through your top 3 GMP risks and give you an honest fit assessment. Confidential, no pressure.