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At FDAInspections.com, we specialize in providing comprehensive, tailored services to help companies prepare for, navigate, and respond to FDA inspections across a wide range of industries, including dietary supplements, cosmetics, pet food, animal health products, food and beverage, medical devices, and biologics. Our expert team offers practical, scalable solutions to help you achieve compliance, avoid costly enforcement actions, and protect your brand reputation.

Our mission: Empower businesses of all sizes to succeed under FDA scrutiny by delivering trusted compliance strategies, inspection readiness, and regulatory support.

Our Core FDA Compliance Services

FDA Inspection Readiness Services

Prepare your facility, records, and team for any FDA inspection with proactive audits and mock inspections.

• Pre-inspection gap assessments

• Mock FDA inspections modeled after official protocols

• Staff interview preparation and training

• Inspection strategy and logistics planning

Learn More About FDA Inspection Readiness

FDA-483 Response and Warning Letter Support

Respond quickly and effectively to FDA findings with expert guidance to restore compliance and credibility.

• Root cause analysis and CAPA development

• Drafting professional 483 responses and evidence packages

• Warning Letter remediation programs

• Mock re-inspections to validate corrections

Learn More About 483 and Warning Letter Support

FDA Label and Claims Compliance Review

Ensure your product labels meet FDA and FTC requirements, and avoid unapproved or misleading claims.

• Supplement Facts, Nutrition Facts, and Ingredient Listing reviews

• Structure/function vs. drug claim analysis

• Cosmetic, pet product, and food labeling audits

• Claims substantiation assistance

Learn More About Label and Claims Compliance

FDA Mock Audits and Facility Compliance Assessments

Identify gaps and risks before FDA inspectors do with thorough facility audits tailored to your product type.

• cGMP compliance audits (21 CFR Parts 111, 117, 210/211, 820)

• FSMA Preventive Controls readiness audits

• Aseptic processing and environmental monitoring assessments (for biologics and sterile products)

Learn More About Mock FDA Audits

FSMA and Preventive Controls Consulting

Stay ahead of FSMA requirements with expert support in developing your food safety and supply chain control programs.

• Food Safety Plan development

• Hazard Analysis and Preventive Controls implementation

• FSVP compliance for importers

• Recall plan creation and testing

Learn More About FSMA Compliance Services

FDA Regulatory Strategy and New Product Launch Support

Launch new supplements, foods, cosmetics, and devices with confidence by building a regulatory foundation from the start.

• Regulatory pathway planning (e.g., 510(k) for devices, NDI notifications for supplements)

• Labeling and marketing compliance for new products

• Facility registration and product listing support

Learn More About Regulatory Strategy Support

Why Choose FDA Inspections .com?

• ✅ Specialized Expertise Across Industries – Dietary supplements, cosmetics, pet food, animal health, foods, beverages, medical devices, and biologics

• ✅ Rapid Response and Practical Solutions – Clear action plans, achievable timelines, measurable results

• ✅ Personalized Service – Scalable support for startups, small businesses, and multinational corporations

• ✅ Confidential and Professional – Trusted by leading brands to deliver audit-ready, defensible compliance systems

We don’t just prepare you for inspections — we help you build a compliance culture that protects your business long-term.

Frequently Asked Questions About FDA Compliance Services

Q: Can FDAInspections.com help small startups and first-time FDA registrants?
A: Absolutely. We specialize in providing scalable services tailored to companies launching their first product or facility.

Q: How quickly can you help after receiving a FDA-483 or Warning Letter?
A: We typically begin initial assessments within 3–5 business days and can assist with urgent response drafting and CAPA planning.

Q: Do you offer remote and onsite services?
A: Yes. We offer both virtual document reviews, remote mock audits, and onsite facility walkthroughs based on your needs and location.

Q: What industries do you support?
A: We serve dietary supplements, foods, beverages, cosmetics, medical devices, biologics, veterinary products, pet foods, and more.