# FDA 483 - Mylan Laboratories Limited - June 26, 2024

Source: https://www.globalkeysolutions.net/records/483/mylan-laboratories-limited/87897492-4940-476d-9c33-d87c45e038b2

> FDA 483 for Mylan Laboratories Limited on June 26, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mylan Laboratories Limited
- Inspection Date: 2024-06-26
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Mylan Laboratories Limited in Pithampur, India, received a Form 483 citing significant deficiencies across multiple quality systems during an inspection from June 14-26, 2024. Key issues include inadequate equipment cleaning leading to potential cross-contamination, scientifically unsound out-of-specification investigations, deficient laboratory controls and test procedures, and concerns regarding data integrity and computer system controls. The findings indicate a broad breakdown in GMP compliance, posing risks to drug product quality and purity.

## Related Documents

- [483 - 2024-06-26](https://www.globalkeysolutions.net/records/483/mylan-laboratories-limited/8d80a740-a39c-41f1-a0fe-76664c670680)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)
- [Pratik S. Upadhyay](https://www.globalkeysolutions.net/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)

Company: https://www.globalkeysolutions.net/companies/mylan-laboratories-limited/b7da9cbd-d5e3-417f-a485-f9e38852b256

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