Drug firm Aurobindo Pharma Ltd on Monday (January 8) said it has received a positive outcome from the US Food and Drug Administration (USFDA) following an inspection of its Unit VI-B, a formulation manufacturing facility located in Telangana’s Chitkul village, in Sangareddy district.
"The U.S. Food and Drug Administration (FDA) had conducted an inspection at the Unit VI-B, a Formulation manufacturing facility of the Company, situated at Chitkul Village, Patancheru Mandal, Sangareddy District, Telangana, from September 22 to September 29, 2023," according to a stock exchange filing.
The FDA conducted the inspection from September 22-29, 2023, and the facility has now been classified as ‘Voluntary Action Indicated’ (VAI) in the Establishment Inspection Report, the company said.
Establishment Inspection Report (EIR)
Based on the inspection and the response given by the company to the USFDA, the latter will release an Establishment Inspection Report (EIR) within 30 days of the inspection.
The EIR reflects the FDA’s official determination of a factory’s GMP compliance. The FDA and the Inspection Classification Database classify the inspection by each project area with one of three classifications. The three classifications displayed are: No Action Indicated (NAI), Voluntary Action Indicated (VAI), and Official Action Indicated (OAI).
Voluntary action indicated
VAI is given when violations are found, but the problems do not justify further regulatory action. Improving GMP compliance is voluntary in this case. The facility can continue selling approved drugs and will also receive approvals of new filings.
Shares of Aurobindo Pharma Ltd ended at ₹1,114, down by ₹10, or 0.89%, on the BSE.
