FDA 483 - Amneal Pharmaceuticals Private Ltd. - April 24, 2018

An FDA inspection of Amneal Pharmaceuticals Pvt Ltd. in Matoda, Gujarat, India, conducted between April 16 and April 24, 2018, revealed a significant observation regarding the firm's quality control unit. The primary issue was the quality control unit's failure to fully adhere to its established responsibilities and procedures, particularly concerning the review and approval of data from contract laboratories.

Investigators observed that Amneal's quality control unit approved critical documents, including analytical method validation reports, extractable and ink migration study reports for packaging, and leachable study reports for container closure systems, without adequately receiving, requesting, or evaluating the raw data generated by their contract laboratories. Furthermore, a deviation initiated by a contract laboratory during a validation study was not reviewed by Amneal's quality control unit, yet the associated report was approved. Similarly, contract laboratory data for active pharmaceutical ingredient testing was accepted and transcribed directly into the firm's Certificates of Analysis without sufficient scrutiny of the underlying raw data.

These findings indicate a lapse in critical quality oversight, which is essential for ensuring product quality and patient safety, under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. Amneal Pharmaceuticals is required to address these observations by implementing corrective actions to ensure comprehensive review and approval processes for all data originating from contract laboratories, thereby achieving compliance with good manufacturing practices.