Tianish Laboratories Private LimitedOctober 19, 2018

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

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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.

Company: Tianish Laboratories Private Limited
Inspection Date: October 19, 2018
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Bijoy Panicker

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ID · 1d3d490f-1c93-4525-a3a5-b4c4c9509f9c