Federal judge approves consent decree against Dakota Laboratories
FDA NEWS RELEASE
For Immediate Release: Sept. 3, 2013 Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA
Federal judge approves consent decree against Dakota Laboratories
Company repeatedly failed to comply with the FDA’s drug manufacturing requirements
The cGMPs serve as the primary regulatory safeguard over drug manufacturing and must be followed by companies to ensure the production of safe and effective products.
Dakota Laboratories and its president must address the violations, have an expert inspect their facilities and certify compliance with the cGMPs, and receive the FDA’s authorization to resume operations.
Dakota Laboratories’ repeated violations of the cGMPs were documented during the FDA’s 2010, 2011, and 2012 inspections of the company. In 2011, the FDA issued the company a warning letter for violating the Federal Food, Drug, and Cosmetic Act.
“The FDA had previously warned the company that corrective actions were necessary, and it ignored our warning,” said Melinda K. Plaisier, associate commissioner for regulatory affairs. “We took today’s action to assure that the firm puts controls in place to protect the public’s health.”
To date, the FDA has not received reports of patient harm related to the use of any of Dakota Laboratories’ products.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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