FDA Compliance Group
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.
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Directory Listing · Records Reviewed
Public records and independent sources have been reviewed.
What this means →- MOQMOQ (Minimum Order Quantity)The smallest production run a manufacturer will accept for an order.
- Not publicly disclosed
- LEAD TIMELead TimeThe time from order placement to finished product delivery.
- Not publicly disclosed
§1Editorial assessment
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.
§2Six-gate readout
Six gates we apply before any name appears in the directory. Each gate is auto-derived from public evidence on this profile.
§3Inspection history
§4Certifications
No certifications on record.
§5Capability matrix
- 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
§6Sources
- FDACG - Dietary Supplements(2026-03-26)
- FDACG - Warning Letter Consultants(2026-03-26)
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.
Disclosures
- No material connection exists between Inventory Ready and this company
For the gate-by-gate readout that produces this vendor's score, see our six-gate scoring readout. The connection map between FDA Compliance Group and other vendors, capabilities, and certifications is in the manufacturer atlas.
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