Institute of Good Manufacturing Practices India®

Warning Letter closed for Dr Reddys Labs’ three Sites: USFDA


The US health regulator closed the  warning letter of a pharmaceutical company, Dr Reddy's Laboratories, for three of its sites in Andhra Pradesh and Telangana, after due evaluation of corrective actions taken by the company.

The company received a warning letter from the US Food and Drug Administration (USFDA) for three of its sites: The oncology formulation manufacturing facility at Duvadda, Visakhapatnam, Andhra Pradesh, and the active pharmaceutical ingredient manufacturing facilities of the company situated at Srikakulum, Andhra Pradesh, and Miryalguda, Telengana, in November 2015.

The company has addressed all the deviations and violations in the said warning letter, as informed by USFDA.