FDA 483 - Apitoria Pharma Private Limited - February 15, 2022

Aurobindo Pharma Ltd. (Unit V) in Sangareddy, India, was cited with five observations during an FDA inspection. The firm demonstrated significant deficiencies in aseptic processing environmental and personnel monitoring, microbiological contamination prevention procedures, and OOS investigations. Additionally, issues were noted with facility design for observation and incomplete batch production records for sterile active pharmaceutical ingredients.