FDA 483 - Apitoria Pharma Private Limited - October 25, 2019

Aurobindo Pharma Limited Unit VIII in Jinnaram Mandal, Telangana, was cited with four observations during an FDA inspection. The inspection revealed deficiencies in equipment cleaning validation, thoroughness of deviation investigations, Quality Unit procedures for stability testing of reprocessed batches, and completeness of batch production records. These issues indicate a lack of adequate controls and documentation in critical manufacturing processes.