# FDA 483 - Tianish Laboratories Private Limited - February 28, 2020

Source: https://www.globalkeysolutions.net/records/483/tianish-laboratories-private-limited/4fd4c4c8-902d-4332-9d2f-c303b655392e

> FDA 483 for Tianish Laboratories Private Limited on February 28, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tianish Laboratories Private Limited
- Inspection Date: 2020-02-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Mylan Laboratories Ltd. - Unit 7, an API manufacturer in Hyderabad, India, was cited for significant deficiencies in its quality systems. Observations included inadequate cleaning validation, lack of solvent traceability, insufficient raw material testing for impurities, unvalidated laboratory test methods, and poor supplier evaluation for solvent recovery vendors. These issues indicate a systemic failure to ensure the quality and purity of APIs and intermediates.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/tomika-l-bivens/089d8723-f740-40ed-a4b9-4619edc4e5cd)
- [Christopher S. Keating](https://www.globalkeysolutions.net/people/christopher-s-keating/94fcfd32-feb5-4b6c-80da-16202f4be01d)

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