homehealthcare NewsUSFDA inspects Dr. Reddy's Duvvada, Vishakapatnam units as US inspections pick up
USFDA inspects Dr. Reddy's Duvvada, Vishakapatnam units as US inspections pick up
Dr Reddy's formulation plants where inspection is likely to have begun on October 18 include FT07 and FT09, located in Duvvada and Vishakapatnam.
The US Food and Drug Administration (USFDA) is inspecting two units of the pharmaceutical company Dr. Reddy's Laboratories as US inspections have picked up CNBC-TV18 learned on Wednesday.
Dr Reddy's formulation plants where inspection is likely to have begun on October 18 include FT07 and FT09, located in Duvvada and Vishakapatnam.
FT07 is a sterile manufacturing plant where oncology products like injectibles, etc for the US markets are manufactured and hence, becomes more relevant in terms of inspection.
In 2015, FT07 was issued a warning letter following which it was inspected by the USFDA in 2018. The US drug regulatory body had issued 8 observations to the unit and eventually, in February 2019, the warning letter was lifted because Dr. Reddy's Laboratories received an Establishment Inspection Report from the USFDA indicating successful closure of the observations.
Watch the accompanying video of CNBC-TV18’s Ekta Batra for more details.
(Edited by : Kanishka Sarkar)
First Published: Oct 20, 2021 2:18 PM IST
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