FDA EIR - Hetero Drugs Ltd. - Unit 1 - February 14, 2020

An FDA inspection of Hetero Drugs Ltd. - Unit 1, located in Bonthapally Village, India, was conducted from February 10-14, 2020. This was a Center for Drug Evaluation and Research (CDER) post-approval and Good Manufacturing Practice (GMP) inspection, specifically targeting an Active Pharmaceutical Ingredient (API) manufacturer. The inspection aimed to ensure compliance with current Good Manufacturing Practices and adherence to regulatory requirements for changes documented in supplemental applications or annual reports, as stipulated by 21 Code of Federal Regulation (CFR) 314.70. The inspection covered critical systems including Quality, Laboratory Controls, Production, Materials, Packaging and Labeling, and Facilities and Equipment. At the conclusion, a one-item Form FDA-483, Inspectional Observations, was issued. The primary violation identified was a deficiency in laboratory control testing for Active Pharmaceutical Ingredients (APIs). Specifically, the firm's testing for API release and stability did not adequately determine conformance to appropriate specifications required for drug products marketed in the United States. This included a lack of stringent laboratory controls necessary to ensure accurate and reliable data, particularly during related substance testing. To address this, Hetero Drugs Ltd. is required to implement enhanced laboratory control procedures to ensure all API testing rigorously meets US market specifications, thereby guaranteeing data accuracy and reliability.