# FDA 483 - Tianish Laboratories Private Limited - October 19, 2018

Source: https://www.keypedia.com/records/483/tianish-laboratories-private-limited/1d3d490f-1c93-4525-a3a5-b4c4c9509f9c

> FDA 483 for Tianish Laboratories Private Limited on October 19, 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: 2018-10-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Mylan Laboratories Limited (Units 1/2) in Hyderabad, India, revealed a significant concern regarding the storage of raw materials and finished products. The firm failed to ensure appropriate temperature conditions, potentially affecting product identity, strength, quality, and purity. This was evidenced by inadequate temperature mapping studies and a lack of continuous temperature monitoring in key warehouses.

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## Related Officers

- [Bijoy Panicker](https://www.keypedia.com/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)

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

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