Roughly half of the supplement facilities FDA inspected in FY2025 walked away with cGMP citations. Part 111 is unforgiving about documentation: master records, batch records, component testing, complaints. We build the evidence file before FDA does.
FDA inspection coverage of supplement facilities keeps rising — and the citations follow the same documentation failures every year.
Investigators see the same gaps at facility after facility. Close them before your inspection.
MMRs copied from a template and never validated against the actual process. Theoretical yields nobody reconciles. A master record that describes a different factory is worse than none — it proves you weren't looking.
Identity testing skipped, supplier COAs accepted without verification, qualification files that can't explain why a supplier was approved. One adulterated component contaminates every batch it touched.
BPRs missing in-process controls, deviations recorded days late or not at all, review signatures applied in batches at month-end. A batch record should tell the story of the batch — holes tell their own story.
Complaint files that can't show an investigation, serious adverse events with no documented evaluation. This is where documentation failures become liability.
The same evidence discipline we built in cannabis — adapted to Subparts E through O and the realities of blending, encapsulation, and contract manufacturing. 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.
Our flagship four-week engagement, baselined against Part 111: personnel, plant and grounds, equipment and utensils, production and process controls, packaging and labeling, holding and distribution, laboratory controls, and records.
You receive a prioritized gap register ranked by risk — and a remediation roadmap sequenced for your next FDA inspection.
Commissioning and qualification for blending, encapsulation, tableting, and packaging lines — IQ/OQ/PQ that reflects actual operating ranges, plus utilities and controlled environments.
Risk-based validation for ERP and batch-execution systems, LIMS, and stability-data platforms — requirements, testing, audit trails, and data integrity for the records FDA reads first.
MMR and BPR design that matches reality, specification setting, component qualification programs, complaint handling and adverse-event procedures, CAPA — and structured 483 and warning-letter response.
Investigators don't grade intentions. They grade records against these requirements.
cGMP for dietary supplements: the complete rule — from personnel and plant design through production controls, lab operations, and record retention.
Subpart O in practice: every batch needs a master record that defines it and a batch record that proves it. Reconciliation of components and yields is not optional.
Identity testing of dietary ingredients, supplier qualification, COA verification. Trust without verification is a 483 waiting to happen.
Serious adverse events must be reported to FDA — and the complaint file must show the investigation behind every decision.
Documentation — not intent. The repeat observations are master manufacturing records that don't match actual production, batch records with missing in-process checks, component identity testing skipped in favor of trusting the COA, and complaint files that can't show an investigation happened.
Yes. Brand owners and specification developers remain responsible for ensuring their products are made under cGMP — you cannot contract away 21 CFR Part 111 liability. Our assessments cover both in-house and contract-manufactured operations, including how you qualify and oversee your CMO.
Yes. The readiness assessment doubles as inspection preparation: we run it the way an investigator would — records first, floor second — and the final readout includes a mock-inspection debrief with the questions your team should be ready to answer.
Speed and sequencing matter. We map each cited violation to its root cause, build the evidence your 15-day response commits to, and order the remediation so the highest-risk findings close first. The goal is a follow-up inspection that finds closures, not repeats.
Our focus is manufacturing compliance — Part 111, records, testing, and quality systems. Label claims need competent substantiation under FTC standards; we flag claim risks we spot during document review and keep the manufacturing file clean so it never undermines your marketing.
Our free 25-point Supplement cGMP Checklist — the same questions auditors ask, as a yes/no self-check. Every unchecked box is a finding waiting to happen.
Start with a free readiness call — supplements focused. We'll walk through your top 3 GMP risks and give you an honest fit assessment. Confidential, no pressure.