Aurobindo Pharma gets US FDA voluntary action notice for Hyderabad unit-VIII1 min read . Updated: 26 Feb 2020, 10:40 AM IST
- US FDA had on 6 Nov issued four observations for the unit
- The inspection at the company’s unit IV is still open and under review
NEW DELHI: Aurobindo Pharma Ltd has received establishment inspection report (EIR) with voluntary action initiated status from the US Food and Drug Administration (FDA) for unit VIII of its active pharmaceutical ingredient manufacturing facility at Gaddapotharam, Hyderabad.
The company had last week told exchanges that it had received an EIR for an inspection conducted at its unit-IV, a general injectable formulation manufacturing facility, in Pashamylaram.
The US FDA had on 6 November issued four observations for the Gaddapotharam unit in Hyderabad after inspecting the site between 21 and 28 October.
Aurobindo Pharma on Friday said the US FDA inspection in November at the company’s unit IV is still open and under review as the regulator has rescinded its EIR, where it classified violations at the plant as minor.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 had said in a filing with exchanges last week.
As per the EIR, which usually signifies closure of an inspection, the 14 adverse observations it had received were classified as voluntary action indicated, meaning the violations were not serious in nature.
At 1021 am, shares of the pharma company were at ₹506.85, up 0.6% in an otherwise weak market with the benchmark Sensex at 40,024.83, down 0.64%.