# FDA 483 - Mylan Laboratories Limited - September 17, 2021

Source: https://www.globalkeysolutions.net/records/483/mylan-laboratories-limited/e58219be-4a66-482b-a88b-0f2be8401934

> FDA 483 for Mylan Laboratories Limited on September 17, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mylan Laboratories Limited
- Inspection Date: 2021-09-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Mylan Laboratories Limited in Hosur, India, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in aseptic processing, including inadequate environmental monitoring, insufficient validation of aseptic processes, poor employee aseptic techniques, and issues with equipment maintenance and air control systems. These findings indicate a lack of robust controls to ensure sterility assurance for drug products.

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## Related Officers

- [Dipesh K. Shah](https://www.globalkeysolutions.net/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)
- [Rita Kabaso](https://www.globalkeysolutions.net/people/rita-kabaso/a8383d6d-b945-4edc-97a4-90944574835d)

Company: https://www.globalkeysolutions.net/companies/mylan-laboratories-limited/519a99b3-febc-4352-9486-0e1b63614973

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