FDA 483 - Intas Pharmaceuticals Limited - December 02, 2022

Intas Pharmaceuticals Limited received a Form 483 citing significant data integrity and quality control failures. Observations included destruction of GMP documents, manipulation of chromatography data to avoid OOS results, inadequate environmental monitoring in aseptic areas, and insufficient process and analytical method validation. These issues indicate a systemic lack of oversight and control over critical manufacturing and testing processes for drug products.