FDA 483 - Tianish Laboratories Private Limited - June 05, 2019

Mylan Laboratories Limited, an API manufacturer in Vizianagaram, India, was cited for significant deficiencies in its manufacturing and quality control processes. The inspection revealed inadequate procedures for preventing contamination and cross-contamination, insufficient investigations into impurity issues, and poorly validated cleaning processes for non-dedicated equipment. Additionally, the firm failed to properly store production equipment and demonstrated critical shortcomings in laboratory testing, instrument calibration, and qualification.