# FDA 483 - Tianish Laboratories Private Limited - April 25, 2025

Source: https://www.keypedia.com/records/483/tianish-laboratories-private-limited/b22c4406-98a1-409e-8e17-75c178441f37

> FDA 483 for Tianish Laboratories Private Limited on April 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tianish Laboratories Private Limited
- Inspection Date: 2025-04-25
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Tianish Laboratories Private Limited, an API manufacturer in Hyderabad, India, revealed two significant observations. The firm failed to perform identity testing for numerous raw materials used in US-market APIs and lacked documentation for this omission. Additionally, equipment used to manufacture APIs was not uniquely identified or properly documented on batch records, and the firm lacked scientific data to support the reuse of certain equipment parts after cleaning.

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## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)

Company: https://www.keypedia.com/companies/tianish-laboratories-private-limited/e097960f-98b1-47f2-877c-d588005879b6

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8