BackUSFDA rescinds inspection report, puts Aurobindo's Andhra unit under review
The company on Tuesday said that it had received an EIR for an inspection conducted at its unit-IVAs per the inspection report the violations were not serious in nature
PremiumNEW DELHI : Aurobindo Pharma Ltd on Friday said that the US Food and Drug Administration’s (USFDA) inspection in November at the company’s unit IV is still open and under review as the regulator has rescinded its establishment inspection report (EIR), where it classified violations at the plant as minor.
“Today... the Company received a communication that the inspection conducted by the US Food and Drug Administration (USFDA) at our aforesaid Unit IV... is still open and under review, by way of rescindment of 90-day VAl letter that was issued by them on February 18...," Aurobindo Pharma said in a filing with exchanges.
The company on Tuesday had said that it had received an EIR for an inspection conducted at its unit-IV, a general injectable formulation manufacturing facility, in Pashamylaram in Andhra Pradesh.
As per the EIR, which usually signifies closure of an inspection, the 14 adverse observations it had received were classified as voluntary action indicated (VAI), meaning that the violations were not serious in nature.
However, with the rescinding of the letter, the US FDA has signaled that the adverse observations could be more serious than what it earlier believed, and could possibly even mean that it could get an official action indicated (OAI) status for the observations.
“The OAI (official action indicated) or the VAI status would not have changed much for the company. Basically, for an injectables plant, a VAI status would have meant that the company can file applications for new products but might not get an approval, and in case of OAI, new product applications cannot be filed," an analyst told Mint on condition of anonymity.
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