# FDA 483 - Mylan Laboratories Limited - September 23, 2022

Source: https://www.globalkeysolutions.net/records/483/mylan-laboratories-limited/457f945a-2cf0-47ff-a725-b22f8dfe412b

> FDA 483 for Mylan Laboratories Limited on September 23, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mylan Laboratories Limited
- Inspection Date: 2022-09-23
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Mylan Laboratories Limited's Hosur Sterile Facility received a Form 483 with six observations related to significant deficiencies in their manufacturing processes for sterile drug products. The inspection revealed issues with equipment performance, environmental monitoring, aseptic process validation, and quality control oversight. These findings indicate a lack of adherence to cGMPs, potentially compromising the sterility and quality of their drug products.

## Related Documents

- [483 - 2021-09-17](https://www.globalkeysolutions.net/records/483/mylan-laboratories-limited/e58219be-4a66-482b-a88b-0f2be8401934)
- [483 - 2024-05-17](https://www.globalkeysolutions.net/records/483/mylan-laboratories-limited/73aaabc3-28a1-4b68-9271-32eb560ddc2c)

## Related Officers

- [Thomas J. Arista](https://www.globalkeysolutions.net/people/thomas-j-arista/37905892-3285-4f3f-b4b5-f963df1e59d3)

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