NEW DELHI, Feb 6: Drug firm Strides Pharma Science Wednesday said it has received the Establishment Inspection Report (EIR) from the US health regulator for its formulations facility in Bangalore.
“The company’s formulations facility (KRSG Gardens) in Bangalore which was inspected by the US Food and Drug Administration (USFDA) in August 2018 and November 2018, has received the Establishment Inspection Report (EIR), thereby confirming the successful closure of the inspections,” Strides Pharma Science said in a BSE filing.
USFDA gives EIR on closure of inspection of an establishment that is the subject of an FDA or FDA-contracted inspection.
The company further noted that the inspection conducted in November 2018 had concluded with zero 483 observations.
As per the USFDA, a Form 483 is issued to a firm’s management at the conclusion of an inspection when investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The flagship facility in Bangalore manufacturers tablets, capsules, liquids, creams ointments, sachets. The facility is the largest for company and supports several current and future products for the US markets.
(PTI)
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