FDA 483 - Indus Medicare Limited - January 23, 2020

An FDA inspection of Indus Medicare Limited, a medical device manufacturer in Medak District, Telangana, India, revealed significant deficiencies in its quality system. The firm failed to establish adequate procedures for design control, process validation, corrective and preventive actions, in-process product acceptance, rework of nonconforming products, and medical device reporting. These issues indicate a systemic lack of control over critical manufacturing and quality processes for their latex condoms.