Aurobindo's manufacturing operations have once again landed the Indian drugmaker in hot water with the U.S. FDA.
Aurobindo's subsidiary Aurolife Pharma received a Form 483 from the FDA outlining 11 observations at a U.S. production plant, the Indian drugmaker said in a filing late last week. The exact nature of the infractions remain unclear, as the FDA has not published the document.
The regulatory rebuke follows an inspection at Aurolife's Raleigh, North Carolina, manufacturing facility that ran from March 24 through April 10, Aurobindo explained in a filing (PDF) Friday with the National Stock Exchange of India and BSE, formerly known as the Bombay Stock Exchange.
The facility produces inhalers and dermatology products.
In its filing, the company characterized the regulator's observations as “procedural in nature” and said that it will promptly submit a response to the FDA detailing corrective measures at the plant.
“We do not expect this development to have any material impact on the current business operations or existing supplies from this facility,” Aurobindo said.
Aurobindo is no stranger to FDA scrutiny. In late 2024, the company recalled more than 103,000 bottles of cinacalcet tablets thanks to unacceptable levels of the potential carcinogen N-nitroso Cinacalcet. The drug is used to treat hyperparathyroidism in patients with chronic kidney disease who are on dialysis.
At the same time, the company also recalled an undisclosed amount of the high blood pressure drug nebivolol, also due to the presence of excess levels of a nitrosamine drug substance-related impurity.
Meanwhile, last August, the FDA slammed Aurobindo’s Eugia manufacturing unit near Hyderabad, India, with a warning letter after the site had received an official action indicated (OAI) notice in May.
An OAI designation is a sort of precursor to more formal reprimands from the FDA indicating that a facility risks running afoul of regulatory and administrative requirements and could pose a danger to public health.
At the time of its warning letter in August, Eugia had been cited with four Form 483s at various facilities throughout India since late 2023. In December 2023, the FDA also issued a citation for a plant in New Jersey that Aurobindo said it planned to sell.