# FDA 483 - Mylan Laboratories Limited - May 24, 2024

Source: https://www.globalkeysolutions.net/records/483/mylan-laboratories-limited/95a4c8d9-54ca-4f0f-a619-a48676753bea

> FDA 483 for Mylan Laboratories Limited on May 24, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mylan Laboratories Limited
- Inspection Date: 2024-05-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Mylan Laboratories Limited in Sinnar, India, was inspected and found to have significant deficiencies across its quality system, including inadequate investigation practices, poor documentation control, and facility maintenance issues. The firm failed to properly document investigation addendums and Global Quality Investigations Team (GQI) feedback, and its equipment and facility showed signs of disrepair and contamination risks. Additionally, the firm did not readily provide requested records, impeding the inspection.

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## Related Officers

- [Wayne D. Mcgrath](https://www.globalkeysolutions.net/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [Arsen Karapetyan](https://www.globalkeysolutions.net/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.globalkeysolutions.net/companies/mylan-laboratories-limited/4fd10a2e-3696-4bd0-82aa-e875143028c0

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