Unveiling Quality Lapses in Intas Pharmaceuticals USFDA 483
Introduction: Discover the comprehensive analysis of the recent FDA inspection at Intas Pharmaceuticals Limited, shedding light on crucial deviations from the current good manufacturing practice (CGMP) guidelines. This scrutiny delves into the intricate details of the pharmaceutical enterprise’s manufacturing facility, highlighting the identified transgressions and their implications. Key Highlights: Thorough FDA inspection between November 22 and December 02, 2022, assessed CGMP compliance in Intas Pharmaceuticals’ India-based drug manufacturing establishment. Quality Control (QC) lapses in ensuring drug product adherence to identity, …