# FDA 483 - Mylan Laboratories Limited - May 27, 2022

Source: https://www.keypedia.com/records/483/mylan-laboratories-limited/16672fe9-8c79-4a84-ac57-c9f728f37244

> FDA 483 for Mylan Laboratories Limited on May 27, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mylan Laboratories Limited
- Inspection Date: 2022-05-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Mylan Laboratories Limited, a sterile manufacturer in Anekal Taluk, Bangalore, Karnataka, India, identified significant deficiencies. The firm's sampling process for in-process and semi-finished products was found inadequate, failing to ensure representative sterility samples under critical conditions. Furthermore, laboratory controls lacked scientifically sound analytical test procedures, impacting the quality assurance of US-marketed sterile injectable products.

## Related Officers

- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.keypedia.com/companies/mylan-laboratories-limited/1a3cc4bb-fac0-4252-89c5-c4ed77ea95f3

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