Biocon Facility Gets Inspection Report From US FDA, Voluntary Action Indicated
This was based on a Good Manufacturing Practice inspection conducted by the agency between June 17 and 21.
Biocon Ltd.'s active pharmaceutical ingredient facility received an Establishment Inspection Report with Voluntary Action Indicated from the US Food and Drug Administration, according to an exchange filing on BSE. The facility is located in Visakhapatnam, Andhra Pradesh.
The term 'Voluntary Action Indicated' implies that while there were some objectionable conditions or practices found during the inspection, these issues are not critical enough for the FDA to take or recommend any administrative or regulatory action.
This was based on a Good Manufacturing Practice inspection conducted by the agency between June 17 and 21.
"Biocon remains committed to the quality, Safety and efficacy of the products manufactured," the company said in a statement in the exchange filing.
Shares of Biocon fell 5.12% to trade at Rs 356.10 apiece, as compared to a 2.68% fall in the NSE Nifty 50.
