# FDA 483 - Mylan Laboratories Limited - January 18, 2019

Source: https://www.globalkeysolutions.net/records/483/mylan-laboratories-limited/7c112c60-9ef9-405f-9cdf-2e08ef2210f7

> FDA 483 for Mylan Laboratories Limited on January 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mylan Laboratories Limited
- Inspection Date: 2019-01-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Mylan Laboratories Limited in Sinnar, India, received a Form 483 with two observations during an inspection from January 14-18, 2019. The inspection revealed deficiencies in laboratory record-keeping for microbiological samples and significant issues with employee training. These observations indicate a need for improved quality control and personnel training practices.

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## Related Officers

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

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

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