About FDAInspections.com
Led by a Former FDA Investigator. Backed by a Team of FDA Compliance Experts.
Meet Our Founder: Pamela Wertalik
Pamela is a former FDA investigator with extensive experience inspecting pharmaceutical, biotech, medical device, dietary supplement, and cosmetic facilities. She has conducted hundreds of FDA inspections, issued countless 483s, and worked across multiple product centers. Today, she leads FDAInspections.com to help companies prepare for audits, respond to regulatory actions, and maintain lasting compliance.
Through Pamela’s direct insight into FDA expectations, clients gain real-world strategies that minimize risk and reduce regulatory exposure.
Our Expert Consultant Team
FDAInspections.com is more than one person. We’ve assembled a national network of former FDA investigators, GMP specialists, CAPA consultants, and regulatory affairs professionals to deliver best-in-class support tailored to your industry and audit challenges.
- Former FDA Investigators & Compliance Officers
- Quality System & GMP Experts
- CAPA & Deviation Investigation Specialists
- Regulatory Affairs & Validation Consultants
- Clinical & Manufacturing Site Auditors
Our Mission
Our mission is simple: to help regulated companies avoid 483s, reduce enforcement risk, and build world-class compliance programs. Whether you need a one-time audit, long-term consulting, or emergency response to an FDA action, we deliver unmatched experience with a practical, fast-moving approach.
Industries We Serve
Our team has worked across all FDA-regulated sectors:
- Pharmaceutical Manufacturers (Rx & OTC)
- Biotech & Biologics Firms
- Medical Device & Diagnostics Companies
- Dietary Supplement Producers
- Cosmetic & Personal Care Product Brands
- Clinical Research Organizations (CROs)
Why Clients Choose FDAInspections.com
- Direct experience from former FDA professionals
- Responsive, results-driven consulting
- Customized inspection prep, mock audits, and response plans
- Webinars, training, and tools that boost team readiness
- Support across the U.S. and internationally
From Fortune 500 pharma companies to early-stage startups, we provide scalable compliance solutions that work.
Work With Us