# FDA 483 - Cipla Limited - November 13, 2024

Source: https://www.keypedia.com/records/483/cipla-limited/53061bbf-ca16-42ce-b780-25e91280d57b

> FDA 483 for Cipla Limited on November 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cipla Limited
- Inspection Date: 2024-11-13
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of CIPLA Limited in Bengaluru, India, revealed significant deficiencies across multiple quality systems for API manufacturing. Issues included inadequate equipment cleaning and maintenance, poorly defined critical process parameters, and insufficient quality unit oversight. The firm also failed to conduct comprehensive investigations into packaging material complaints and lacked proper laboratory controls.

## Related Documents

- [483 - 2019-07-19](https://www.keypedia.com/records/483/cipla-limited/024e48d2-35ef-49f9-ad8b-e77be6e252e9)
- [483 - 2019-07-19](https://www.keypedia.com/records/483/cipla-limited/3f8bbc67-313f-4442-bdc2-7deda4dfa0a7)

## Related Officers

- [Investigator](https://www.keypedia.com/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)
- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

Company: https://www.keypedia.com/companies/cipla-limited/cefc1473-6852-4af7-b996-0730dc0834bb

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8