483
Tianish Laboratories Private LimitedTianish Laboratories Private Limited – FDA 483, Apr 25, 2025
Record Details
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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ID · b22c4406-98a1-409e-8e17-75c178441f37
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