Violations of current good manufacturing practice and labeling requirements cited
SILVER SPRING, Md., Aug. 6 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration is seeking an injunction in federal court against Regenerative Sciences LLC, of Broomfield, Colo., citing violations of current good manufacturing practice (cGMP) that cause its cultured cell product to be adulterated. The product is also misbranded due to the lack of adequate directions for use and the failure to bear the "Rx only" symbol.
The company's cultured cell product is derived from a patient's bone marrow or fluid surrounding the patient's joints (synovial fluid). The cells are grown, processed, and mixed with drug products outside the body before being injected back into the patient.
Regenerative Sciences' cultured cell product is not approved by the FDA, and no adequate and well-controlled studies have been done to demonstrate its safety or effectiveness for any indication.
"FDA recognizes the importance of the development of novel and promising new therapies," said Karen Midthun, M.D., acting director of FDA's Center for Biologics Evaluation and Research. "However, when companies like Regenerative Sciences fail to comply with FDA laws and regulations, they put the public's health at risk."
The complaint for the injunction was filed Aug. 6, 2010, by the Justice Department on behalf of the FDA in the U.S. District Court for the District of Columbia, against Regenerative Sciences and three of its employees, Christopher J. Centeno, M.D., John R. Schultz, M.D., and Michelle R. Cheever. The injunction would permanently prevent the company and cited individuals from adulterating and misbranding the cultured cell product while the product, or one or more of its components, is held for sale after shipment in interstate commerce.
Regenerative Sciences has agreed to cease production of the cultured cell product while the case is pending.
The FDA warned Regenerative Sciences about its cGMP violations as recently as June 2010. The company failed to make sufficient corrections, and the conduct of the individuals cited in the complaint demonstrates refusal to comply with the law.
For more information:
FDA Web page on Tissue & Tissue Products http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/default.htm
Media Inquiries: Shelly Burgess, 301-796-4651, [email protected]
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration