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

An FDA inspection of Gland Pharma Limited, Units I+II, located in Hyderabad, Telangana, India, was conducted from July 25 to August 2, 2024. The inspection resulted in a Form FDA 483, identifying significant deficiencies in the firm's manufacturing practices for human drug products, indicating a need for improved adherence to Good Manufacturing Practices. Major violations included inadequate procedures to prevent microbiological contamination of sterile drug products. Specifically, Aseptic Processing Simulations (Media Fills) were found deficient, failing to adequately track all types and durations of interventions during both simulations and actual filling processes. Environmental monitoring in aseptic processing areas also showed shortcomings, with operators sanitizing before finger dab sampling, a lack of dynamic non-viable particle monitoring in critical Grade A zones, and insufficient microbial growth specifications for personnel in these areas. The quality control unit exhibited issues, evidenced by frequent aseptic filling line breakdowns and recurring laboratory incidents and out-of-specification results for product release testing, often attributed to equipment failures. The firm also lacked an appropriate preventive maintenance program for its production and analytical equipment. Gland Pharma Limited is required to address these observations by implementing corrective actions to ensure regulatory compliance.