FDA Compliance Group
Regulatory consulting firm offering NDI submissions, GRAS determinations and nonclinical safety assessments.
- LEAD TIME
- Not publicly disclosed
Overview
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.
Certifications
No certifications on record.
Capabilities
- PRODUCT TYPES
- CAPABILITIES
- New dietary ingredient (NDI) notifications · GRAS or food-additive filings · GMP audits, mock inspections or training · FDA inspection, 483, warning-letter or detention response · Former FDA staff on the team
Sources
- FDACG - Dietary Supplements(2026-03-26)
- FDACG - Warning Letter Consultants(2026-03-26)
What we couldn't verify
We did not visit this company on site. See the limits that apply to every listing.
- Physical office location not publicly disclosed
- Specific consultant names and credentials not listed on website
Dietary supplement manufacturers must comply with 21 CFR Part 111 (cGMP). What Part 111 requires
The connection map between FDA Compliance Group and other vendors, capabilities, and certifications is in the manufacturer atlas.
Enforcement screening: included in Inventory Ready's most recent completed pass against FDA's published recall datasets (2026-07-09). Method and limits →
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