FDA warning letter prevention – Pharma GMP

FDA Form 483: Understanding and Responding Effectively

digi — Sun, 01 Jun 2025 14:45:40 +0000

FDA Form 483: Understanding and Responding Effectively FDA Form 483: How to Interpret and Respond to Inspection Observations Effectively When the US FDA concludes a GMP inspection and identifies significant issues, it issues a Form 483. For pharmaceutical manufacturers, this document signals potential noncompliance with 21 CFR Parts 210 and 211. An effective and timely...

Introduction to US FDA GMP Compliance Framework

digi — Sat, 31 May 2025 23:17:26 +0000

Introduction to US FDA GMP Compliance Framework Overview of the US FDA GMP Compliance Framework for Pharmaceutical Manufacturers The United States Food and Drug Administration (US FDA) plays a pivotal role in ensuring the quality and safety of drugs through its comprehensive Good Manufacturing Practice (GMP) compliance framework. All pharmaceutical products intended for the US...