# FDA 483 - Aurobindo Pharma Ltd - July 21, 2023

Source: https://www.keypedia.com/records/483/aurobindo-pharma-ltd/33feb8af-e76c-4b11-bcf0-12ef27f2e475

> FDA 483 for Aurobindo Pharma Ltd on July 21, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aurobindo Pharma Ltd
- Inspection Date: 2023-07-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Aurobindo Pharma Ltd in Medchal, Telangana, revealed three significant observations. These included a lack of validated equipment cleaning procedures, poor facility maintenance with a leaking ceiling in the quality control laboratory, and a failure to follow established laboratory control mechanisms, evidenced by contaminated test media. These issues indicate deficiencies in the firm's manufacturing and quality control processes.

## Related Documents

- [483 - 2017-04-18](https://www.keypedia.com/records/483/aurobindo-pharma-ltd/96bc5d60-2e90-4ff4-a4e9-85bdabf692db)
- [483 - 2018-12-14](https://www.keypedia.com/records/483/aurobindo-pharma-ltd/f2b68946-1a20-4c83-b130-07cf6893348c)
- [483 - 2019-05-24](https://www.keypedia.com/records/483/aurobindo-pharma-ltd/ed01b8a9-88db-401b-b91c-4b4446c83461)

## Related Officers

- [Regulatory Affairs Specialist](https://www.keypedia.com/people/andrew-le/573464c0-de29-4f64-ab33-62543b7fe719)
- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.keypedia.com/companies/aurobindo-pharma-ltd/169fdedf-28b5-446b-84f4-65ca9bc54a1a

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