FDA 483 - GPT Pharmaceuticals Private Ltd - June 24, 2019

GPT Pharmaceuticals Pvt. Ltd. in Hyderabad, India, was inspected by the FDA from June 24-28, 2019, and received a Form 483 with 10 observations. The inspection revealed significant deficiencies across quality control, laboratory operations, and manufacturing processes, including inadequate OOS investigations, data integrity issues, unvalidated test methods, and poor equipment cleaning. These issues indicate a systemic failure to adhere to cGMP requirements, raising concerns about the quality and purity of drug products.