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

Amneal Pharmaceuticals Pvt Ltd. in Matoda, India, was inspected from April 16-24, 2018, and received a Form 483 for significant deficiencies in its quality control unit. The firm's quality control unit failed to adequately review raw data and deviations from contract laboratories for various tests, including method validations and API testing, before approving data and releasing products. This indicates a critical breakdown in oversight of outsourced testing and product release procedures.