483
Apotex Research Private LimitedApotex Research Private Limited – FDA 483, Nov 17, 2017
Record Details
An FDA inspection of Apotex Research Private Limited in Bangalore, India, revealed significant deficiencies in manufacturing process validation, laboratory controls, and quality unit procedures. The firm failed to thoroughly investigate discrepancies, maintain equipment, and ensure proper documentation and tracking of materials and samples. Repeat observations were noted regarding control procedures and the stability testing program, indicating systemic issues.
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ID · e4899c56-8df1-4d9f-8486-9e68edd1627b
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