# FDA 483 - Cipla Limited - February 17, 2023

Source: https://www.globalkeysolutions.net/records/483/cipla-limited/0c4d85ed-d21a-4440-8835-7e2f111667e9

> FDA 483 for Cipla Limited on February 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cipla Limited
- Inspection Date: 2023-02-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Cipla Limited in Pithampur, India, revealed significant deficiencies across multiple systems, including failures in aseptic processing, environmental monitoring, data integrity, and quality control. The firm failed to thoroughly investigate discrepancies, maintain sterile conditions, control computer systems, and adequately handle numerous patient complaints and field alert reports. These issues indicate a systemic lack of adherence to cGMP regulations for both sterile and non-sterile drug manufacturing.

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- [483 - 2023-02-17](https://www.globalkeysolutions.net/records/483/cipla-limited/72954a77-6423-4064-b768-46c816145d00)

## Related Officers

- [Saleem A. Akhtar](https://www.globalkeysolutions.net/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)
- [Quality System Specialist](https://www.globalkeysolutions.net/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

Company: https://www.globalkeysolutions.net/companies/cipla-limited/de9dc5de-fbea-4a7d-ab5b-a398b6ed442e

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