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

Source: https://www.globalkeysolutions.net/records/483/mylan-laboratories-limited/73aaabc3-28a1-4b68-9271-32eb560ddc2c

> 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 Biological Products Operations - Division I
- Summary: Mylan Laboratories Limited, a sterile drug manufacturer in Hosur, India, was cited for significant deficiencies in aseptic processing during an FDA inspection. Observations included inadequate cleaning and disinfection systems, insufficient validation of aseptic processes, and failure to investigate microbiological contamination. The firm also failed to submit a required Field Alert Report for an OOS stability failure and deviated from written test procedures without justification.

## Related Documents

- [483 - 2021-09-17](https://www.globalkeysolutions.net/records/483/mylan-laboratories-limited/e58219be-4a66-482b-a88b-0f2be8401934)
- [483 - 2022-09-23](https://www.globalkeysolutions.net/records/483/mylan-laboratories-limited/457f945a-2cf0-47ff-a725-b22f8dfe412b)

## Related Officers

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

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