# FDA 483 - Tianish Laboratories Private Limited - September 13, 2022

Source: https://www.globalkeysolutions.net/records/483/tianish-laboratories-private-limited/7f45d719-db20-49a5-a320-27591070c678

> FDA 483 for Tianish Laboratories Private Limited on September 13, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tianish Laboratories Private Limited
- Inspection Date: 2022-09-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Mylan Laboratories Limited – Unit 7, an API manufacturer in Patancheru, India, revealed significant deficiencies, including a repeat observation for failure to validate analytical test methods for APIs and intermediates. The firm also failed to adequately clean and maintain equipment, had an inadequate procedure for investigating critical quality events, and conducted a flawed cleaning validation study. These issues indicate a lack of control over manufacturing processes and quality systems.

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## Related Officers

- [Pratik S. Upadhyay](https://www.globalkeysolutions.net/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)
- [Quality System Specialist](https://www.globalkeysolutions.net/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

Company: https://www.globalkeysolutions.net/companies/tianish-laboratories-private-limited/3aa20920-7f85-4cd2-806b-a3cfb4548be8

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