FDA Orders Biomedical Tissue Services, Ltd., to Cease Manufacturing and to Retain Existing Inventories of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)

On Feb 3., 2006, the FDA's investigates BTS and finds there are serious deficiencies in manufacturing practices. As a result, agency reason believes the company may not manufacture, since that would present a danger to public health. The risk is of communicable disease transmission, according to Margaret O'K. Glavin, FDA's Associate Commissioner for Regulatory Affairs.

Thus, the FDA's is enforcing the current regulatory framework for Human Tissue and Cellular and Tissue Based Products (HCT/Ps). This will provide strong measures to prevent the introduction, transmission, or spread of communicable diseases by HCT/Ps according to Jesse L. Goodman, MD, MPH, director of FDA's Center for Biologics Evaluation and Research.

You can view a copy of the BTS Order of Cessation at: www.fda.gov/cber/compl/bts013106.htm.