Hyderabad: The U.S. Food and Drug Administration (USFDA) has classified Dr. Reddy’s Laboratories’ facility in Srikakulam, Andhra Pradesh, as Voluntary Action Indicated (VAI) following an inspection.
The Inspection
The regulator had issued a Form 483 with three observations after the Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection of the FTO-SEZ Process Unit-02 in Srikakulam, conducted between July 20 and July 29.
“We wish to inform the U.S. FDA has classified the inspection outcome as ‘voluntary action indicated (VAI)’ and concluded that the inspection is officially closed,” Dr. Reddy’s said in a filing on Wednesday.
What the Classifications Mean
VAI is one of three classifications the USFDA issues after inspecting pharma facilities. It means that while objectionable conditions or practices were found, the regulator is not prepared to take or recommend any administrative or regulatory action.
Under Official Action Indicated (OAI), the second classification, the USFDA recommends regulatory and/or administrative actions. The third, No Action Indicated (NAI), conveys that no objectionable conditions or practices were found during the inspection.
