The FDA has placed four Chinese and Indian generic drug facilities on the so-called “Red List” that bans them from shipping products to the U.S. for failing to pay required fees and not meeting identification requirements.
The action by the regulatory agency falls under the Generic Drug User Fee Amendments of 2012.
“Placing these firms on import alerts is the first time the FDA is using the authority provided by Congress to enforce GDUFA’s user fee provisions," Kris Baumgartner, an agency spokesman, told the Regulatory Affairs Professionals Society’s publication Focus.
Named by the FDA to the ban are Jiangsu ZW Pharmaceuticals and Wuxi Kaili Pharmaceutical, both of China and both which received warning letters in 2015; and Fleming Laboratories and Sharon Bio-Medicine, both of India. Fleming got an FDA warning letter in 2014, and Sharon Bio-Medicine in 2015.
Additionally, the FDA pointed out that under the Federal Food, Drug, and Cosmetic Act, drugs produced at facilities that require fees that have not been paid or self-identifying information has not been produced “are deemed to be misbranded and may be subject to refusal of admission to the U.S.”
The enforcement is part of the FDA’s crackdown in recent years on manufacturing facilities that consistently fail to meet the agency’s standards. Many of those facilities that have come under scrutiny in the past year are located across Asia, with the majority in China and India.
- here’s the RAPS article