Cipla Ltd.May 26, 2025

FDA 483 - Cipla Ltd. - May 26, 2025

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Record Details

Cipla Ltd., an API manufacturer in Bangalore, India, was cited for inadequate cGMP controls during an FDA inspection. The firm failed to extend investigations into related deviations, lab incidents, and other quality events, leading to a lack of trending for recurring issues. Additionally, the inspection noted numerous failed batches and concerns regarding the accuracy and reproducibility of QC laboratory test methods.

Company: Cipla Ltd.
Inspection Date: May 26, 2025
Product Type: Drugs
Office: Division of Human and Animal Food East V Compliance Branch
Person: Roger F. Zabinski (Investigator)

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ID · 1e5d4e6e-c770-4dc1-bfc6-14c2d583e30c