FDA 483 - AARTI PHARMALABS LIMITED - June 23, 2022

Aarti Industries Limited, an API manufacturer in Dombivil (E), Thane, India, was cited for two observations during an FDA inspection. The firm failed to conduct temperature mapping studies for warehouses storing intermediate drug products with specific storage requirements. Additionally, the company did not perform analytical method verification studies for test methods transferred from a sponsor for API drug products.