Dr. Reddy’s Laboratories’ API manufacturing plant at Miryalaguda, has been audited by the US Food and Drug Administration (USFDA) and the audit has been completed on February 21, 2017. The company has been issued a Form 483 with three observations, which it is addressing.
Earlier, in January, South Korea’s Mezzion, a drug company was seeking damages from Dr. Reddy’s Laboratories in a New Jersey court for committing fraud by hiding significant deficiencies and misrepresenting compliance in its manufacturing practices. The suit stated that Dr. Reddy’s repeatedly represented to Mezzion that it was compliant with FDA regulations, and that it hid its misconduct from Mezzion.
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.