FDA 483 - Hetero Labs Limited - August 12, 2021

An FDA inspection of Hetero Labs Limited, an API manufacturer in Sanga Reddy District, Telangana, India, revealed multiple significant deficiencies. The firm failed to establish appropriate specifications for APIs, validate test procedures for impurities, and ensure adequate cleaning and maintenance of manufacturing equipment. These issues indicate a lack of control over product quality and purity, potentially impacting APIs supplied to the US market.