483
Cipla LimitedCipla Limited – FDA 483, Nov 13, 2019
Record Details
Cipla, Ltd. in Raigad, Maharashtra, was cited for significant quality control and data integrity issues during an FDA inspection. Observations included failures in thoroughly investigating out-of-specification results, releasing API batches without proper investigation, and a lack of authority within the quality control unit. Additionally, employees demonstrated inadequate training regarding data integration and audit trail review.
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ID · 67da4b81-fb4f-4e4b-a030-ca8a381868ef
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