FDA Compliance Group
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Profile updated: March 26, 2026
FDA Compliance Group (FDACG) is a regulatory consulting firm whose consultants have all worked for the FDA as investigators and/or compliance officers, or have extensive experience in the dietary supplement industry. The firm specializes in helping supplement manufacturers respond to FDA Form 483 inspectional observations and warning letters. Services include pre-audit preparedness, on-site FDA inspection support, 21 CFR Part 111 compliance audits, NDI notification submissions, GRAS determinations, and nonclinical product safety assessments. FDACG also conducts manufacturing quality and laboratory systems evaluations to identify compliance gaps before FDA inspectors find them.
Min. Order
Lead Time
Not publicly disclosed
Product Types
Capabilities
FDA Form 483 Response, Warning Letter Response, Pre-Audit Preparedness, On-Site FDA Inspection Support, 21 CFR Part 111 Compliance Audits, NDI Notifications, GRAS Determinations, Former FDA Investigators on Staff
Certifications
Key Regulatory Concepts
Dietary supplement manufacturers must comply with 21 CFR Part 111 (Current Good Manufacturing Practice for dietary supplements). This includes requirements for personnel, facilities, equipment, production, laboratory operations, and record-keeping.
Review Notes
Regulatory consulting firm staffed by former FDA investigators and compliance officers. Specialized in FDA enforcement response (Form 483, warning letters). 21 CFR Part 111 compliance auditing and NDI notifications. Physical location not publicly disclosed. Consultant-specific credentials not individually listed.
Sources
- FDACG - Dietary Supplements(2026-03-26)
- FDACG - Warning Letter Consultants(2026-03-26)
Disclosures
- No material connection exists between Inventory Ready and this company
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