# FDA 483 - Tianish Laboratories Private Limited - December 10, 2018

Source: https://www.globalkeysolutions.net/records/483/tianish-laboratories-private-limited/43ded1bd-5aa7-4a90-af85-e84043884097

> FDA 483 for Tianish Laboratories Private Limited on December 10, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tianish Laboratories Private Limited
- Inspection Date: 2018-12-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Mylan Laboratories Limited (Unit 8) in G. Chodavaram Village, India, was cited for significant deficiencies during an FDA inspection. The firm failed to adequately investigate unexpected results, including impurities and unknown peaks, and exhibited poor maintenance and cleanliness in its manufacturing facilities. Additionally, analytical methods used for drug substance testing were not consistent with validated conditions.

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- [483 - 2019-06-05](https://www.globalkeysolutions.net/records/483/tianish-laboratories-private-limited/fc1fbb08-9ad0-422c-ab6c-497b290bd248)

## Related Officers

- [Senior Lead Reviewer and Intercenter Consult Team Leader](https://www.globalkeysolutions.net/people/nayan-j-patel/0436f014-4b1b-4e54-8df0-576d51a354b2)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/darren-s-brown/389a4d1f-7f34-42cd-bdc8-5bebd41aff56)

Company: https://www.globalkeysolutions.net/companies/tianish-laboratories-private-limited/7b05f5f2-461b-4a95-bfaa-a8c773250712

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