FDA 483 - Apitoria Pharma Private Limited - February 09, 2019

Aurobindo Pharma Limited, Unit XI, an API manufacturer in Pydibhimavaram, India, was cited for significant deficiencies in laboratory controls, inadequate investigations into impurities, and insufficient master production batch records. The inspection revealed failures to properly investigate unknown peaks, validate analytical methods, assess cleaning validation, and document critical manufacturing steps. These issues indicate a lack of robust quality control and data integrity practices.