FDA 483 - Teva API India Private Ltd. - July 18, 2023

Teva API India Private Limited, an API and intermediate manufacturer in Gajraula, India, received a Form FDA 483 with seven observations. The inspection revealed significant deficiencies across quality control, data integrity, equipment maintenance, personnel training, and facility upkeep. Key issues include inadequate quality unit oversight, uninvestigated equipment failures, widespread data integrity concerns with computerized systems and documentation, and poor facility maintenance.