FDA 483 - SHODHANA LABORATORIES PRIVATE LIMITED - May 23, 2019

An FDA inspection of Shodhana Laboratories Limited, an API drug manufacturer in Hyderabad, India, from May 20-23, 2019, identified a critical deficiency in their manufacturing equipment cleaning validation procedure. The firm's cleaning validation study was found to be inaccurate and insensitive, failing to address worst-case conditions and utilizing inadequate sampling and analysis methods. This indicates a significant concern regarding the assurance of clean equipment for drug manufacturing.