FDA 483 - Cipla Limited - July 19, 2019

An FDA inspection of Cipla, Ltd - Virgonagar Site, an API manufacturer in Bangalore, India, revealed significant deficiencies across multiple areas. The firm's investigations into out-of-specification results were inadequate, and equipment used for critical process parameters was not properly designed, installed, or qualified. Additionally, preventative controls for electronic inventory and warehousing systems were ineffective, process validations were inconsistent, and stability studies were not conducted using commercial packaging systems. The firm also lacked written packaging procedures and failed to provide requested records during the inspection.