At FDA Inspections, we provide expert regulatory consulting and inspection readiness services to businesses across all FDA-regulated sectors. Our mission is to help companies achieve, maintain, and defend compliance — protecting public health, strengthening brands, and enabling growth.

Whether you’re launching a new product, preparing for your first FDA inspection, or responding to a 483 or Warning Letter, we deliver practical solutions grounded in real-world regulatory expertise.

Explore the industries we serve and discover how we help companies succeed across the FDA landscape.

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Industries Covered by FDA Regulation

Food and Beverage

The FDA regulates the safety, manufacturing, labeling, and distribution of human and animal foods under the Food Safety Modernization Act (FSMA).

• Facility registration and hazard analysis

• Food labeling and claims compliance

• Foreign Supplier Verification Program (FSVP) support

🔗 Learn about FSMA Regulations (FDA.gov)

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Dietary Supplements and Nutraceuticals

Supplements must meet FDA requirements under DSHEA and 21 CFR Part 111 for cGMP manufacturing and truthful labeling.

• Supplement label review and substantiation

• New Dietary Ingredient (NDI) submissions

• GMP audit preparation

🔗 Explore Dietary Supplement Compliance (FDA.gov)

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Pharmaceuticals (Drugs)

Pharmaceuticals are regulated under strict cGMP standards (21 CFR Part 210/211) to ensure their safety, efficacy, and quality.

• Mock FDA drug inspections

• 483 response and CAPA development

• Pre-Approval Inspection (PAI) preparation

🔗 FDA Pharmaceutical Quality Resources (FDA.gov)

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Medical Devices

Medical device companies must comply with the Quality System Regulation (21 CFR Part 820) and submit products through 510(k), PMA, or De Novo pathways.

• Medical device quality audits

• Technical file and Design History File (DHF) review

• Postmarket surveillance consulting

🔗 Learn About Medical Device Regulations (FDA.gov)

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Cosmetics and Personal Care Products

The FDA regulates cosmetics primarily for safety and truthful labeling. Improper claims may reclassify a product as a drug.

• Ingredient compliance and safety checks

• Cosmetic labeling reviews

• Voluntary Cosmetic Registration Program (VCRP) support

🔗 FDA Cosmetic Laws and Regulations (FDA.gov)

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Tobacco Products and Vaping

The Center for Tobacco Products (CTP) regulates the manufacture, marketing, and sale of tobacco and vaping products.

• PMTA submission support

• Labeling and health warnings compliance

• Marketing and advertising reviews

🔗 FDA Tobacco Regulatory Resources (FDA.gov)

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Veterinary and Animal Health

The FDA oversees animal drugs, pet foods, and veterinary medical devices through its Center for Veterinary Medicine (CVM).

• Animal drug GMP audits

• Veterinary food labeling and FSMA compliance

• Veterinary device submissions and inspections

🔗 Explore FDA Veterinary Oversight (FDA.gov)

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Biologics and Advanced Therapies

Biologics like vaccines, blood products, and gene therapies require rigorous FDA regulatory approvals and oversight.

• Biologics License Applications (BLA) consulting

• Gene and cell therapy regulatory strategy

• GCP and GMP compliance support

🔗 Learn About FDA Biologics Programs (FDA.gov)

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Why Work With FDA Inspections?

• ✅ Cross-industry regulatory expertise

• ✅ Customized inspection readiness and compliance solutions

• ✅ Rapid response for 483s and Warning Letters

• ✅ Trusted support from startups to global corporations

• ✅ Nationwide and international services available

Our consultants don’t just know the regulations — we’ve lived them. We provide practical, defensible compliance strategies you can trust.

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Frequently Asked Questions About FDA-Regulated Industries

Q: What industries are regulated by the FDA?
A: The FDA regulates food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco products, animal health products, biologics, and radiation-emitting products.

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Q: How does FDA regulation differ between industries?
A: Each industry has specific regulatory frameworks. For example, foods follow FSMA, supplements follow DSHEA, drugs must meet cGMPs, and devices comply with QSR. Inspection priorities and compliance risks vary by sector.

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Q: Can FDAInspections.com help my company even if we’ve already been inspected?
A: Yes. We offer post-inspection support, including FDA-483 response drafting, Warning Letter remediation, and long-term CAPA development.

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Q: Are FDA Inspections ‘s services available internationally?
A: Absolutely. We assist international manufacturers exporting to the U.S. with FDA inspection preparation, FSVP compliance, and regulatory consulting.