FDA 483 - Gland Pharma Limited, Units I+II Pashamylaram Site - August 02, 2024

An FDA inspection of Gland Pharma Limited, Units I+II in Hyderabad, India, from July 25 to August 2, 2024, revealed significant deficiencies in the manufacturing of sterile drug products. The firm was cited for inadequate aseptic processing simulations, poor environmental monitoring practices, and a quality control unit that failed to properly follow procedures, leading to repeated equipment breakdowns and out-of-specification results.