FDA Inspection Preparation & Compliance by Former FDA Investigators | FDAInspections.com
Get expert help with FDA inspections, 483 responses, GMP audits, and readiness strategies. Trusted compliance support for labs, manufacturers & brands.
Led by a Former FDA Investigator
Hi, I’m Pamela. I spent years conducting FDA inspections across pharmaceuticals, biotech firms, medical device companies, and dietary supplement manufacturers. Now I help businesses like yours avoid FDA 483s, warning letters, and enforcement actions by strengthening your quality systems and inspection preparedness.
FDA Compliance Services
- FDA 483 Risk Assessments & Compliance Audits
- Mock FDA Inspections & Audit Preparation
- 483 and Warning Letter Response Support
- GMP, QMS, and CAPA System Consulting
- FDA Webinars, Training, and Documentation Reviews
Industries We Support
We specialize in providing FDA regulatory consulting, inspection readiness, and quality system support across all FDA-regulated industries, including:
- Pharmaceutical Manufacturers
- Biotechnology Companies
- Medical Device Manufacturers
- Dietary Supplement Companies
- Clinical Research Organizations (CROs)
- Cosmetic & Personal Care Product Firms
If you’re in a regulated industry, we’ll help you stay FDA compliant, inspection ready, and audit resilient.
Free FDA Inspection Readiness Checklist
Download our expert-developed checklist to prepare your site and documentation for FDA inspections in 2025. A must-have for QA, RA, and compliance teams in pharma, biotech, device companies.
FDA Compliance Webinars & Training
Attend live and on-demand training sessions on the latest FDA expectations, data integrity best practices, inspection trends, and CAPA execution. Stay current and proactive with monthly regulatory webinars.
Regulatory & Quality Job Board
Find FDA compliance and QA/RA job openings or post new roles. Recruit top regulatory talent or explore career opportunities in FDA-regulated industries.
Blog
Top 10 FDA 483 Observations of 2024—and How to Avoid Them in 2025
As regulatory pressures grow and the US Food and Drug FDA refines its inspection protocols, companies in the life sciences
US FDA Issues Warning Letter to DeGrave Dairy for Illegal Drug Residue
On February 27, 2017, a US Food and Drug Administration (USFDA) Warning Letter was issued to the two owners of
US FDA Issues Warning Letter to Lucky Pacific Corp and Kamli International Co. Ltd.
On March 2, 2017, a US Food and Drug Administration (USFDA) Warning Letter was issued to seafood importers, Lucky Pacific
The United States and European Union will be able to use each other’s Pharmaceutical Inspections
The United States and the European Union (EU) amended the 1998 U.S.-EU Mutual Recognition Agreement for Pharmaceutical Inspections. The US