Industries We Service
FDA Inspection Support Across Every Regulated Industry
Practical FDA inspection readiness and regulatory consulting for food, drugs, devices, cosmetics, supplements, biologics, tobacco, and animal health companies.
FDA-regulated industry coverage
Industries Covered
FDA-Regulated Industries We Support
At FDA Inspections, former agency investigators help regulated companies prepare for inspections, respond to FDA observations, and keep quality systems ready for review.
Food and Beverage
FDA food oversight covers safety plans, labeling, facility registration, supplier controls, and records that inspectors expect to see ready.
- FSMA readiness
- Facility registration
- Food labeling review
Dietary Supplements
Supplement companies need cGMP records, truthful claims, ingredient support, and supplier controls aligned with DSHEA and 21 CFR Part 111.
- Label and claims review
- NDI submission support
- GMP audit preparation
Pharmaceuticals
Drug manufacturers face strict cGMP expectations for production, quality systems, lab controls, validation, and data integrity.
- Mock FDA drug inspections
- 483 response planning
- PAI preparation
Medical Devices
Device firms must keep design controls, complaint handling, CAPA, technical files, and postmarket records inspection-ready.
- QSR and QMSR audits
- DHF review
- Postmarket support
Cosmetics and Personal Care
Cosmetic brands need safety support, compliant labels, adverse event processes, and claims that do not turn products into drugs.
- MoCRA readiness
- Ingredient checks
- Cosmetic label review
Tobacco and Vaping
Tobacco and vape companies need disciplined product records, labeling controls, marketing reviews, and PMTA support.
- PMTA support
- Warning label review
- Marketing compliance
Veterinary and Animal Health
Animal health teams work with FDA requirements for animal drugs, pet foods, veterinary devices, and related manufacturing records.
- Animal drug GMP audits
- Pet food FSMA checks
- Veterinary device submissions
Biologics and Advanced Therapies
Biologics, vaccines, blood products, and cell or gene therapies need tight controls across quality, clinical, and manufacturing records.
- BLA support
- Cell and gene strategy
- GCP and GMP readiness
Why Work With Us
Inspection Support Built Around FDA Expectations
Our consultants have worked inside FDA-regulated environments and know what investigators ask for when they review facilities, records, and response plans.
Former FDA Inspection Experience
Former agency investigators review your systems with the same practical focus FDA brings to inspections.
Learn MoreCAPA and 483 Response Support
Get help turning observations into clear corrective actions, owners, dates, and evidence FDA can review.
Learn MoreReadiness for Growing Teams
Support for startups, expanding sites, and global teams preparing for routine or triggered inspections.
Learn MoreU.S. and International Support
Manufacturers exporting to the U.S. get help aligning records, quality systems, and response plans.
Learn MoreCommon Questions
Frequently Asked Questions
FDA oversight covers food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco products, animal health products, biologics, and radiation-emitting products.
Each sector has its own rules. Foods follow FSMA, supplements follow DSHEA, drugs follow cGMP requirements, and devices follow QSR or QMSR expectations.
Yes. The team supports FDA-483 responses, Warning Letter remediation, CAPA planning, and follow-up readiness work.
Yes. International companies exporting to the U.S. can get support with inspection preparation, FSVP compliance, and FDA response work.