# FDA 483 - Cipla, Ltd. - May 06, 2024

Source: https://www.keypedia.com/records/483/cipla-ltd/7c8e1395-291d-4698-ad4d-88a7bde50b11

> FDA 483 for Cipla, Ltd. on May 06, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cipla, Ltd.
- Inspection Date: 2024-05-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Cipla Ltd., an API and Finished Dosage Manufacturer in Kurkumbh, Maharashtra, India, identified a significant lapse in their quality system. The firm failed to fully follow the responsibilities and procedures applicable to its quality control unit. Specifically, uncontrolled "SAMPLE LOCATION CHART" documents were found in use for stability samples within multiple stability chambers, indicating a failure to adhere to established document control procedures.

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## Related Officers

- [Santos E. Camara](https://www.keypedia.com/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)
- [Haitao Li](https://www.keypedia.com/people/haitao-li/62ce7565-d80f-4570-962a-8e6bfc88d0c1)

Company: https://www.keypedia.com/companies/cipla-ltd/f726d9c8-4fe7-456e-848c-f9ef86f00e4f

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1