Dietary Supplement FDA Inspections
Dietary Supplement FDA Inspection Readiness and Compliance Support
Former FDA investigators help supplement manufacturers, brand owners, CMOs, distributors, and importers prepare for cGMP inspections, respond to observations, and keep records ready for review.
Supplement inspection readiness
Supplement Support
FDA Dietary Supplement Services and Product Areas
Supplement inspections put Part 111 records, supplier qualification, identity testing, labels, claims, complaints, and adverse event records under review.
FDA Inspection Readiness Audits
Former FDA investigators review supplement quality systems, batch records, labels, supplier files, and facility controls before FDA arrives.
- 21 CFR Part 111 audits
- SOP and record review
- Facility walkthroughs
cGMP and Part 111 Support
Supplement firms need master manufacturing records, batch production records, QC review, and testing controls that match Part 111.
- MMR and BPR checks
- Quality control review
- Testing records
483 and Warning Letter Response
Teams get help with observation review, root cause work, CAPA planning, response drafting, and evidence packages.
- Observation analysis
- CAPA planning
- Response support
Label and Claims Review
Supplement Facts panels, ingredient listings, disclaimers, and structure-function claims need support before labels reach market.
- Supplement Facts review
- Structure-function claims
- Disease-claim checks
Supplier Qualification and FSVP
Imported ingredients and finished supplements need supplier files, identity testing, COA checks, and FSVP records.
- Supplier audits
- Identity testing
- Import records
Vitamins and Minerals
Vitamin and mineral products need potency support, daily value checks, stability records, and ingredient verification.
- Potency records
- Daily value checks
- Stability support
Herbal and Botanical Products
Botanical supplements need raw material identity testing, adulterant controls, contaminant review, and claims support.
- Botanical identity
- Adulterant checks
- Claims support
Sports Nutrition and Weight Management
Sports and weight products need careful ingredient qualification, warning language, serving size review, and claim substantiation.
- Stimulant review
- Serving-size checks
- Marketing claims
Why Work With Us
Supplement Inspection Support Built Around FDA Expectations
Our consultants focus on the records FDA asks to see, from MMRs and BPRs to supplier files, testing evidence, label support, complaints, and CAPA documentation.
Part 111 Record Readiness
Prepare master manufacturing records, batch production records, specifications, and QC documentation.
Learn MoreLabel and Claims Control
Review Supplement Facts panels, disclaimers, ingredient names, and claims before labels reach market.
Learn MoreCAPA and 483 Support
Turn inspection findings into corrective actions, owner assignments, dates, and evidence FDA can review.
Learn MoreSupplier and Import Support
Check supplier files, identity testing, COA verification, and imported ingredient documentation.
Learn MoreCommon Questions
Frequently Asked Questions
FDA may inspect supplement firms through routine surveillance, consumer complaints, adverse event reports, import concerns, or follow-up to prior observations.
Common findings include incomplete batch production records, weak identity testing, missing specifications, poor QC documentation, and unsupported claims.
FDA does not pre-approve most supplement labels before sale, but companies must use compliant Supplement Facts panels, disclaimers, ingredient names, and claims.
Yes. Brand owners, startups, CMOs, distributors, and importers can get help with inspection readiness, label review, supplier records, and response work.