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QSS helps dietary supplement companies prepare for FDA inspections before they happen. If your documentation hasn't been reviewed against 21 CFR Part 111, or an inspection is on the horizon, we can tell you exactly where your facility stands and what needs to change.
Dietary supplement facilities operating in the U.S. are required to comply with 21 CFR Part 111, which sets the current Good Manufacturing Practices (cGMPs) for how supplements are produced, packaged, labelled, and held. This regulation covers quality control systems, master and batch production records, supplier qualification, ingredient identity testing, and complaint handling, all of which must be documented and inspection-ready at any time.
An FDA inspection can be routine, risk-based, or triggered by a complaint or adverse event report. In each case, the expectation is the same: your facility, your documentation, and your operational systems need to demonstrate consistent compliance. Gaps in any of these areas can result in Form 483 observations, warning letters, import alerts, or enforcement action.
A pre-audit assessment with QSS gives you a clear picture of where your facility stands before FDA arrives, and the time to fix what needs addressing.
We evaluate your operations against 21 CFR Part 111 requirements, identify deficiencies, confirm that your data matches facility registration details, and flag compliance risks before they become inspection findings.
We review your SOPs, master and batch production records, product formulas, labels, and claims to confirm they are complete, accurate, and inspection-ready.
We conduct a simulated FDA inspection that examines your facility layout, sanitation practices, process flow, and equipment setup against cGMP standards, so you know exactly what an actual inspection would find.
We assess supplier qualification processes, ingredient traceability, in-process controls, and product release procedures to confirm your quality system functions as required.
You receive a detailed findings report with prioritized recommendations and clear next steps. We can then work alongside your team to implement corrections, update documentation, and prepare for registration or inspection.
We provide continued support for facility registration renewals, responses to FDA inquiries, and inspection follow-up so your compliance program stays current.
Explore articles, blogs, and videos on FDA inspections, 21 CFR Part 111, cGMP requirements, and dietary supplement compliance.
21 CFR Part 111 sets the cGMP requirements for dietary supplement manufacturing. It covers how products are produced, packaged, labelled, and held, and requires documented quality control systems, master and batch production records, supplier qualification, ingredient identity testing, and complaint handling procedures. Everything must be current and accessible at the time of inspection.
It’s not legally required, but it is a sound approach. Identifying compliance gaps before registration, or before an inspection, gives you the time to address them without the pressure of an active regulatory review. Facilities that are inspected without preparation are far more likely to receive Form 483 observations.
You need current SOPs, master and batch production records, ingredient specifications, certificates of analysis, training logs, complaint files, and distribution records. We review all of these as part of our audit process and help you identify and address anything that is incomplete or out of date.
You are required to respond with a corrective action plan within the timeframe specified. We can help you prepare a complete, accurate response and address the underlying issues to prevent escalation.
Yes. Any facility that manufactures, processes, packs, or holds dietary supplements for distribution in the U.S. is subject to FDA inspection, regardless of where it is located. Foreign facilities also need a designated U.S. Agent. We support both foreign and domestic manufacturers through this process.
The audit and document review phase typically takes 10 to 20 business days. Remediation timelines vary depending on the number and complexity of findings. We scope each engagement based on your facility’s size and current compliance status.
Only if you have qualified the supplier and verified ingredient identity as required under 21 CFR Part 111. In some cases, independent testing is still required. We assess your supplier qualification program and advise on what testing obligations apply.
A routine inspection is scheduled as part of FDA’s oversight program and is generally risk-based. A for-cause inspection is triggered by a specific issue such as a consumer complaint, adverse event report, or tip. Both require the same level of documentation and operational readiness. Our pre-audit process prepares your facility for either scenario.