# FDA 483 - Cipla Limited - November 13, 2019

Source: https://www.globalkeysolutions.net/records/483/cipla-limited/67da4b81-fb4f-4e4b-a030-ca8a381868ef

> FDA 483 for Cipla Limited on November 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cipla Limited
- Inspection Date: 2019-11-13
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: 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.

## Related Documents

- [483 - 2024-04-04](https://www.globalkeysolutions.net/records/483/cipla-limited/74d8c438-1c03-4c72-8870-adebf8fceb40)

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.globalkeysolutions.net/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

Company: https://www.globalkeysolutions.net/companies/cipla-limited/ca77117b-0afe-4b51-bdc2-82ee1e242ec8

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4