FDA orders two companies to cease manufacturing human cells and tissues

The U.S. Food and Drug Administration (FDA) has ordered Donor Referral Services (DRS), a human tissue-recovery firm, of Raleigh, NC, and its owner, Philip Guyett, to immediately cease all manufacturing operations, and to retain human cells, tissues, and cellular and tissue-based products (HCT/Ps) after an inspection found serious deficiencies in its manufacturing practices, including those governing donor screening and record keeping.

The order to cease manufacturing and retain HCT/Ps requires DRS and Philip Guyett to immediately suspend any and all manufacturing steps, including but not limited to the recovery and shipment of HCT/Ps. FDA's inspection identified serious violations of the regulations, including the failure to establish and maintain procedures for manufacturing steps performed by DRS. In addition to the above stated violations, FDA also found several instances where records provided by DRS to another HCT/P establishment were at variance with the official death certificates FDA had obtained from the state where the death occurred.

"Patient safety is at the forefront of today's action," said Margaret O'K Glavin, Associate Commissioner, Office of Regulatory Affairs. "Allowing the firm to continue to manufacture would present a danger to public health by increasing the risk of communicable disease transmission."

Firms that recover HCT/Ps obtain tissue from human donors and send the tissue to establishments that process it for use in implantation or transplantation. HCT/Ps are used in a variety of procedures that can save lives, repair limbs, relieve pain or enhance a patient's quality of life.

This action to protect public health is being taken under the agency's new tissue regulations which took effect on May 25, 2005. Among other mandates, the regulations require firms to properly screen and test donors and, when needed, they enable FDA to take swift action in the interest of public health.

"While most tissues are obtained and manufactured using appropriate protections, some operators are not following acceptable practices," said Jesse L. Goodman, MD, MPH, director of FDA's Center for Biologics Evaluation and Research. "Today's action is a clear sign of FDA's intent to put a stop to any practices which place patients at unneeded risk."

The regulations require that establishments process HCT/Ps in a way that does not cause contamination or cross-contamination and that prevents the introduction, transmission, or spread of communicable disease through the use of the HCT/P. To date, FDA has not received reports of adverse reactions (e.g., transmission of communicable disease to recipients) in any patients who may have received the tissues in question. All tissue products initially recovered from human donors by DRS have been recalled. The agency will continue to investigate DRS' activities, monitor the recalls to account for all distributed tissue and work cooperatively with tissue processors and appropriate federal, state and local authorities. FDA will take further actions as needed.

You can view a copy of the DRS Order of Cessation at: www.fda.gov/cber/compl/drs081806.htm