FDA 483 - Glenmark Pharmaceuticals Limited - March 15, 2019

An FDA inspection of Glenmark Pharmaceuticals Limited in Colvale Bardez, Goa, revealed significant deficiencies in their non-sterile drug manufacturing operations. The firm was cited for inadequate equipment cleaning, repeated failures in out-of-specification (OOS) investigations, and a lack of proper quality control unit oversight. Further issues included scientifically unsound sampling plans and an unreliable stability program, indicating systemic problems with quality assurance and product release.