USFDA concludes inspection of Aurobindo Pharma's unit XI | 17 November, 2022

The inspection at Aurobindo Pharma's unit XI is concluded by the United States Food and Drug Administration, the firm said in a stock regulatory filing on 16 November.

"Subsequent to our responses for the aforesaid observations, we have received an Establishment Inspection Report (EIR) classifying the inspection as Voluntary Action Indicated (VAI) from the US FDA and with this, the inspection at our Unit XI is concluded," Aurobindo Pharma said.

The firm Unit XI, an API Non-antibiotic manufacturing facility situated at Pydibhimavaram in Andhra Pradesh's Srikakulam District, was inspected by the (USFDA) in February 2019 and was issued a warning letter in June 2019.

Later the unit was further inspected by USFDA from July 25 to August 2 2022. According to the USFDA site, the company's unit 11 has been classified as a Voluntary Action Indicated status. As per details, the approval with Voluntary Action Indicated (VAI) means objectionable practices were found at the manufacturing unit, however USFDA does not recommend any administrative or regulatory action.

With the action prescribed by USFDA, Aurobindo Pharma in October said it will recall products from the US market. USFDA said AuroMedics Pharma LLC, a unit of Hyderabad-based Aurobindo Pharma, is recalling 88,080 vials of Tranexamic acid injection used to control or prevent excessive or heavy bleeding during various conditions like dental procedures in patients.

(Source: Mint)