The flagship facility in Bengaluru manufacturers tablets, capsules, liquids, creams ointments, sachets
Strides Pharma Science has received the Establishment Inspection Report (EIR) from the US health regulator for its formulations facility in Bengaluru. “The company’s formulations facility (KRSG Gardens) in Bengaluru which was inspected by the US Food and Drug Administration (US FDA) in August 2018 and November 2018, has received the EIR, thereby confirming the successful closure of the inspections,” Strides Pharma Science said in a BSE filing.
US FDA 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 US FDA, 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 Bengaluru 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.