# FDA 483 - Mylan Laboratories Limited - Unknown Date

Source: https://www.keypedia.com/records/483/mylan-laboratories-limited/4c91fbd7-6c18-41c4-8f08-ca2e411cd51b

> FDA 483 for Mylan Laboratories Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mylan Laboratories Limited
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Mylan Laboratories Limited in Sinnar, India, a drug product manufacturer, revealed significant deficiencies across its operations. Observations included failures in quality control unit procedures, inadequate investigation of production errors, and a lack of established written procedures for in-process controls. Additionally, the facility's building and employee amenities were found to be improperly maintained.

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## Related Officers

- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Dipesh K. Shah](https://www.keypedia.com/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

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

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