US drug regulator issues establishment inspection report for Aurobindo Pharma's Telangana unit

Aurobindo Pharma on Thursday received Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) Company’s Unit III, a formulation manufacturing facility situated at Bachupally Village, Telangana. The US drug regulator classified EIR as Voluntary Action Indicated. The report indicates closure of inspection.

In an official communication, company said that the US Administration had inspected Telangana Unit from July 14- 21, 2023. Earlier on July 21, US FDA had issued Form 483 with three observations for the unit and at that time the company had said that it will respond within stipulated timelines and work with it to close the observations.

On February 14, it was reported that USFDA had concluded inspection of Telangana Unit with voluntary action indicated in its EIR. The unit is an Active Pharmaceutical Ingredients (API) and before this it was inspected in November 2022 from 10-18.