483
Teva API India Private Ltd.Teva API India Private Ltd. – FDA 483, Jul 18, 2023
Record Details
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.
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