FDA 483 - GPT Pharmaceuticals Private Ltd - January 27, 2023

An FDA inspection of GPT Pharmaceuticals Private Ltd. in Hyderabad, India, revealed two significant observations. The firm failed to exercise appropriate controls over computer systems, leading to data integrity concerns with audit trails and user access. Additionally, the company's laboratory controls were found to be inadequate, specifically regarding microbiological contamination testing and cleaning validation for drug products and intermediates.