# FDA 483 - Mylan Laboratories Limited - February 07, 2020

Source: https://www.keypedia.com/records/483/mylan-laboratories-limited/ddc8b37b-414f-413c-9639-04f25dcb98e6

> FDA 483 for Mylan Laboratories Limited on February 07, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mylan Laboratories Limited
- Inspection Date: 2020-02-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Mylan Laboratories Limited in Sinnar, India, revealed significant deficiencies in their quality control unit, including failures to investigate product-impacting alarms and trend defects. The firm also failed to thoroughly investigate unexplained discrepancies and batch failures, leading to the release of out-of-specification products. Furthermore, a repeat observation highlighted inadequate training and qualification for visual inspectors, raising concerns about product quality assurance.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

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