Pharmaceutical and medical device companies operating in the U.S. must comply with strict Good Manufacturing Practices (GMPs) to ensure public safety, efficacy, and product quality. Yet, despite rigorous internal controls, FDA Form 483s—inspectional observations—remain common across the industry.
In their recent article published in BioPharm International (August 29, 2025), our colleagues Patrick Falvey, Georgia Sloboda, Sarah DeDonder, and Lauren Schoukroun-Barnes examine the inspection findings most often tied to documentation practices and procedures, including:
- Standard operating procedures (SOPs)
- Incomplete or inadequate deviations
- Non-conformances
The article also provides strategies companies can adopt to address and prevent regulatory non-compliance.
Read the full article here.