Cipla LimitedNovember 13, 2019

FDA 483 - Cipla Limited - November 13, 2019

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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.

Company: Cipla Limited
Inspection Date: November 13, 2019
Product Type: Drugs
Office: Center for Veterinary Medicine
Person: Taichun Qin (Consumer Safety Officer, Drug Specialist)

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ID · 67da4b81-fb4f-4e4b-a030-ca8a381868ef