Aurobindo's manufacturing operations have once again landed the Indian drugmaker in hot water with the U.S. FDA. | ...

Aurobindo Pharma Ltd on Friday said the US health regulator has issued a Form 483 with 11 observations to the Raleigh plant ...

At the conclusion of the inspection, the US FDA issued a Form 483, listing 11 observations. Aurobindo Pharma characterised ...

We are in the process of drafting a very robust response to each of the observations in the Form 483. According to Equirius, the unit received Form 483 with 12 observation that runs through 38 pages.

Gland Pharma Ltd on Tuesday said the US health regulator has issued a Form 483 with three observations to its facility at JNPC, Visakhapatnam. The US Food and Drug Administration (USFDA ...

Aurobindo Pharma received a Form 483 with 11 observations from the USFDA for its Raleigh plant in North Carolina. The company ...

2016 and issued six observations in Form 483. The US drug regulator issued the observations for its oncology formulation facility at Duvvuda in Visakhapatnam‘s SEZ. The site is important given ...

The US Food and Drug Administration (USFDA) had conducted inspection at the plant from March 24, 2025, to April 10, 2025, Aurobindo Pharma said in a regulatory filing.

"Wholly owned subsidiary Claris Injectables has received five 483s during the inspection on the plant 1 - Clarion 1," the Ahmedabad-headquartered pharma company in its filing on August 26 ...