FDA 483 - Apitoria Pharma Private Limited - August 01, 2022

The FDA inspected Aurobindo Pharma Limited, Unit XI, an API manufacturer in Pydibhimavaram, India, revealing significant quality system deficiencies. Observations included inadequate equipment cleaning procedures leading to visible residue and rust, a failure to thoroughly investigate numerous instrument errors and a market complaint, and a lack of adherence to quality control unit procedures for deviation initiation and contemporaneous data recording. These issues indicate a concerning lack of control over manufacturing processes and quality systems.