# FDA 483 - Cipla Limited - August 26, 2022

Source: https://www.keypedia.com/records/483/cipla-limited/3c4414ab-af3a-425d-bb60-2b91ddd03159

> FDA 483 for Cipla Limited on August 26, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cipla Limited
- Inspection Date: 2022-08-26
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Cipla Limited received a Form 483 citing significant deficiencies in its aseptic manufacturing processes. Issues include inadequate environmental monitoring, insufficient aseptic process validation, poor cleaning and disinfection practices, and a lack of control over computer systems and data integrity. The firm also failed to adequately follow quality control procedures and validate cleaning hold times.

## Related Documents

- [483 - 2016-08-30](https://www.keypedia.com/records/483/cipla-limited/72b519eb-58af-4d80-991a-d0eb593f645f)
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- [483 - 2019-01-28](https://www.keypedia.com/records/483/cipla-limited/96151c31-a5c8-4cfa-b564-ee38cfa14dad)
- [483 - 2024-06-21](https://www.keypedia.com/records/483/cipla-limited/8db1e1bc-0bc5-4334-9558-e7aa003c3b7d)
- [483 - 2018-01-25](https://www.keypedia.com/records/483/cipla-limited/00e64667-a769-4e4b-bbed-c435ef1a7485)

## Related Officers

- [Teresa I. Navas](https://www.keypedia.com/people/teresa-i-navas/43f747c0-18c2-4630-bab9-936204aa93aa)
- [Regional Manager](https://www.keypedia.com/people/jonah-s-ufferfilge/6bcd2028-9aca-4704-bd7b-c835874fad9d)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

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

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