# FDA 483 - Mylan Laboratories Limited - January 09, 2023

Source: https://www.globalkeysolutions.net/records/483/mylan-laboratories-limited/4fe084f9-5115-4616-8f39-47604e5dad50

> FDA 483 for Mylan Laboratories Limited on January 09, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mylan Laboratories Limited
- Inspection Date: 2023-01-09
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: An FDA inspection of Mylan Laboratories Limited (SFF) in Bangalore, Karnataka, revealed significant deficiencies in their testing laboratory operations. The firm failed to establish scientifically sound test procedures for Capillary Electrophoresis impurity methods, relying heavily on unoptimized manual integration. Additionally, laboratory records were found to be incomplete, as not all versions of generated electropherograms were included or reviewed.

## Related Documents

- [WARNING_LETTER - 2015-02-13](https://www.globalkeysolutions.net/records/warning_letter/mylan-laboratories-limited/62000dbc-fddc-45df-b125-f15ffc0e77d2)
- [483 - 2020-02-28](https://www.globalkeysolutions.net/records/483/mylan-laboratories-limited/cca43c7c-0783-44c6-940e-2b1010e0ac93)

## Related Officers

- [Research Specialist II](https://www.globalkeysolutions.net/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [ Investigator, Consumer Safety Officer](https://www.globalkeysolutions.net/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)

Company: https://www.globalkeysolutions.net/companies/mylan-laboratories-limited/977203cc-5cbe-49ea-9b42-0b797ade4b5e

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321