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

Source: https://www.keypedia.com/records/483/mylan-laboratories-limited/11d00bff-dfd7-4025-bb11-14b795593155

> 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 Inspections and Investigations
- Summary: Mylan Laboratories Limited in Sinnar, India, was cited for significant quality system deficiencies during an FDA inspection. Observations include inadequate investigation documentation, lack of control over laboratory records, unscientific root cause analyses, and poor facility and equipment maintenance. These issues indicate a systemic breakdown in quality control and data integrity practices.

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## Related Officers

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

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8