# FDA 483 - Cipla Limited - January 28, 2019

Source: https://www.globalkeysolutions.net/records/483/cipla-limited/96151c31-a5c8-4cfa-b564-ee38cfa14dad

> FDA 483 for Cipla Limited on January 28, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cipla Limited
- Inspection Date: 2019-01-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Cipla Limited in Verna, India, was inspected by the FDA from January 21-28, 2019, regarding its manufacturing of drug products. The inspection revealed significant deficiencies across multiple systems, including inadequate quality control investigations, poor aseptic practices, incomplete master production records, unsuitable equipment design, insufficient drug product testing and release procedures, and an incomplete stability program. These observations indicate a broad range of issues impacting product quality and regulatory compliance.

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## Related Officers

- [Cheryl A. Clausen](https://www.globalkeysolutions.net/people/cheryl-a-clausen/2306b2bc-8f01-4f77-ba2d-1a3186d6f6fc)
- [Angela Glenn](https://www.globalkeysolutions.net/people/angela-glenn/5ba5e1e2-883b-42c4-aae0-3564820723e8)

Company: https://www.globalkeysolutions.net/companies/cipla-limited/6b5864ed-07a2-4861-b424-021018d4f7e9

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