Information
Prepare for your FDA inspection with our comprehensive compliance checklist. Designed for manufacturers, packagers, labelers, and holders of dietary supplements, this checklist helps ensure you meet the Current Good Manufacturing Practices (CGMP) regulation (21 CFR Part 111). Identify and correct any areas of non-compliance, ensure all required documentation is complete and readily accessible, and use it to train your staff. Achieve audit-readiness and sustained compliance to minimize the risk of a Form FDA 483 or Warning Letter.
Gain peace of mind
Using our compliance checklist offers three key benefits:
1. Risk Mitigation and Legal Protection: Minimize the risk of fines, product seizures, recalls, import alerts, or facility shutdown by proactively identifying and correcting deficiencies in cGMP compliance (21 CFR Part 111), accurate labeling, permissible claims, and required documentation.
Streamline your audit
2. Streamlined Inspection Process and Preparedness: Ensure all personnel, processes, and records are "audit-ready" for a smoother, faster inspection. Quickly locate required documents (e.g., batch production records, complaint files, quality control testing results) and train personnel effectively.
Who is this for?
This checklist is designed for facilities involved in manufacturing, packaging, labeling, and holding (storage and distribution) of dietary supplements. It is used by quality control professionals, compliance managers, and internal auditors to perform self-audits and prepare for official FDA inspections. The checklist aligns with the Current Good Manufacturing Practices (CGMPs) for Dietary Supplements (21 CFR Part 111).
Why our checklist?
Our checklist stands out due to its detail, relevance to the audit process, and practical applicability for FDA dietary supplement compliance (21 CFR Part 111 - Current Good Manufacturing Practices, or cGMPs). We break down the regulations into specific, auditable actions and required records, detailing exactly what the investigator will be looking for.
