Mumbai: Caraco Pharmaceuticals, a subsidiary of Sun Pharma, Tuesday said it has received a warning letter from US Food and Drug Administration, or, FDA, over the company’s manufacturing facility in Detroit.
The points noted in the 31 October warning letter include, among other things, the inadequate and untimely investigation by the quality control unit of certain incidents at the facility contrary to the company’s standard operating procedures.
The FDA inspection was held in May 2008.
Sun Pharma holds 76% in Caraco Pharmaceuticals and it is listed in New York Stock Exchange.
The FDA may in near term withhold approval of pending new drug applications listing the facility as the manufacturer until Caraco’s responses to the observations have been clarified and explanations provided to the satisfaction of the regulator, it said.
Caraco said it would respond to the FDA within 15 days.
“The company is committed to working cooperatively and expeditously with the FDA to resolve the matters indicated in its letter,” Caraco said in its website.
Detroit-based Caraco develops, manufactures, markets and distributes generic and private-label pharmaceuticals to wholesalers, distributors and drugstore chains.