US Food and Drug Administration (USFDA) has completed audit of Dr. Reddy’s Laboratories’ Formulations Manufacturing Plant - 3 at Bachupally, Hyderabad on April 28, 2017. The company has been issued a Form 483 with 11 observations.
These observations are mostly procedural in nature, reflecting the need to improve people capabilities and strengthen documentation and laboratory systems. The pharma major will address them comprehensively within the stipulated time.
Dr. Reddy’s Laboratories is a multinational pharmaceutical company based in Hyderabad, Telangana in India. It manufactures and markets a wide range of pharmaceuticals in India and overseas.
