You are here: Home » Companies » News
Business Standard

Aurobindo Pharma gets 14 observations from the USFDA for Hyderabad plant

The observations issued by the USFDA notifies the company's management of objectionable conditions at the inspected facility

Press Trust of India  |  New Delhi 

Aurobindo Pharma

has received 14 observations from the US health regulator for its Hyderabad-based plant, according to a regulatory filing.

The US Food and Drug Administration (USFDA) inspected company's Unit IV, a general injectable formulation manufacturing facility situated at Pashamylaram, Hyderabad from November 4-13, said.

"At the end of the inspection, we have been issued a Form 483 with 14 observations," it added.

The company believes that none of the observations are related to data integrity issues and, it will respond to the within the stipulated timeline, said.

The observations issued by the notifies the company's management of objectionable conditions at the inspected facility.

First Published: Thu, November 14 2019. 20:20 IST
RECOMMENDED FOR YOU