FDA Seeks Injunction Against Cultured Cell Product Maker

US Pharm. 2010;35(9):71. 

Citing violations of current good manufacturing practice that caused the company's cultured cell product to be adulterated, the FDA sought an injunction in federal court against Regenerative Sciences LLC of Broomfield, Colorado, in August. The product, which is not FDA approved, is also misbranded because of the lack of adequate use directions and the failure to bear the “Rx only” symbol. The product is derived from a patient's bone marrow or the fluid surrounding the patient's joints. The cells are then grown, processed, and mixed with drug products outside the body before being injected back into the patient.

“FDA recognizes the importance of the development of novel and promising new therapies,” said Karen Midthun, MD, 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.” Regenerative Sciences has agreed to cease production of the cultured cell product while the case is pending.