FDA WARNING_LETTER - TCA Cellular Therapy, LLC - March 31, 2011

An FDA inspection of TCA Cellular Therapy, LLC (TCA) from February 22 to March 31, 2011, revealed significant violations of regulations governing investigational new drugs (21 CFR Part 312) and human cells, tissues, and cellular and tissue-based products (HCT/Ps) (21 CFR Part 1271). TCA, acting as a sponsor and biological drug product manufacturer, failed to ensure investigations were conducted according to investigational plans and adequately monitor ongoing studies. Specific deficiencies included administering autologous investigational products to individuals not enrolled in IND studies, some while INDs were on clinical hold, and administering allogeneic cells when INDs were limited to autologous use. The firm also initiated clinical investigations without an effective IND or submitting required protocol amendments for new indications, including treating underage subjects. Furthermore, TCA administered investigational products in violation of clinical holds. For allogeneic HCT/Ps, TCA failed to determine donor eligibility through proper screening and testing for relevant communicable disease agents, including Treponema pallidum, HTLV types I and II, and Cytomegalovirus. The FDA deemed TCA's April 19, 2011, response to the Form FDA 483 inadequate. TCA must provide written documentation of corrective actions within fifteen business days to address these serious violations concerning human subject protection and communicable disease prevention, or face further regulatory action.