483
Apotex Research Private LimitedApotex Research Private Limited – FDA 483, Mar 15, 2024
Record Details
Apotex Research Private Limited in Bangalore, India, received a Form 483 during an FDA inspection from March 11-15, 2024. The firm was cited for failing to adequately investigate unexplained discrepancies and anomalous results, and for not establishing written procedures for production and process controls. Additionally, the quality control unit's responsibilities and procedures were not fully followed, indicating significant deficiencies in their quality system.
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ID · ff53473b-8a4e-4ca7-a6a0-fc07672a264a
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