FDA 483 - PolyPeptide Laboratories Private Limited - November 22, 2024

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from November 18 to November 22, 2024, at PolyPeptide Laboratories Private Limited, an Active Pharmaceutical Ingredient (API) manufacturer in Ambernath, Maharashtra, India, two significant observations were noted on a Form FDA 483. Firstly, the Quality Unit demonstrated inadequate controls over its packaging material suppliers. Specifically, the firm failed to sufficiently verify the authenticity of supplier certificates of analysis for pyrogen-free packaging materials. These materials are critical, as they are used as containers for the company's US-marketed active pharmaceutical ingredients. This observation highlights a deficiency in vendor qualification and incoming material control processes, which are fundamental to ensuring product quality and safety. Secondly, the inspection revealed systemic issues within the firm's deviation handling system. The Quality Unit failed to close multiple deviation investigations within the established timeframe of nine days, as stipulated by their own procedure, SOP-IG-013-9.0. Furthermore, there was a failure to request extensions when more time was needed to finalize these investigations. Approximately 27 such instances were identified since 2021, indicating a pattern of non-compliance with internal procedures for managing deviations. These observations signify lapses in the company's quality management system, particularly concerning supplier qualification and timely resolution of quality incidents. PolyPeptide Laboratories Private Limited is required to respond to the FDA 483 with a detailed plan of corrective and preventive actions to address these deficiencies and ensure compliance with regulatory standards.