FDA 483 - Gland Pharma Limited, Units I+II Pashamylaram Site - November 07, 2019

An FDA inspection of Gland Pharma Limited, a parenteral drug manufacturer in Patancheru, India, revealed significant deficiencies across multiple areas. Observations included inadequate investigations into discrepancies and foreign materials, insufficient microbial control measures, and failures in laboratory controls for product quality and validation. Additionally, the firm was cited for not taking representative samples of components for testing.