FDA 483 - Apitoria Pharma Private Limited - February 02, 2019

An FDA inspection of Aurobindo Pharma Ltd, Unit 9, a manufacturer of starting materials and advanced intermediates in Gundlamachanoor Village, India, revealed significant deficiencies. The firm's investigations into genotoxic impurities were inadequate, and its cleaning validation processes for non-dedicated equipment were found to be deficient. Further issues included inadequate corrective and preventive actions, unvalidated analytical methods, and failures in laboratory equipment calibration and data integrity.