# FDA 483 - Mylan Laboratories Limited - May 17, 2024

Source: https://www.keypedia.com/records/483/mylan-laboratories-limited/d4e40876-3354-4df3-ba51-e04ce26608b8

> FDA 483 for Mylan Laboratories Limited on May 17, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mylan Laboratories Limited
- Inspection Date: 2024-05-17
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Mylan Laboratories Limited, a sterile drug manufacturer in Hosur, India, was inspected and cited for significant deficiencies in aseptic processing, cleaning validation, and quality control. Observations included inadequate cleaning and disinfection systems, insufficient aseptic process validation, failure to investigate recurring microbial contamination, and non-compliance with Field Alert Report requirements. These issues indicate a high risk to the sterility and quality of drug products.

## Related Documents

- [483 - 2021-09-17](https://www.keypedia.com/records/483/mylan-laboratories-limited/e58219be-4a66-482b-a88b-0f2be8401934)
- [483 - 2022-09-23](https://www.keypedia.com/records/483/mylan-laboratories-limited/457f945a-2cf0-47ff-a725-b22f8dfe412b)
- [483 - 2024-05-17](https://www.keypedia.com/records/483/mylan-laboratories-limited/73aaabc3-28a1-4b68-9271-32eb560ddc2c)

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)
- [GDUFA Pharmaceutical Investigator](https://www.keypedia.com/people/kevin-p-regan/b870e1f2-017c-44ab-bc99-1ca99b474a04)

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

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3