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

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.