FDA Orders Human Tissue-Recovery Firm To Shut Down
August 19th, 2006 by RespiteMatch.comAugust 18, 2006 11:00 p.m. EST
Yvonne Lee - All Headline News Staff Reporter
Washington, D.C. (AHN) - The Food and Drug Administration (FDA) orders a human tissue-recovery firm, Donor Referral Services (DRS), to immediately cease operations.
The FDA also ordered the company 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.
An inspection of the firm uncovered serious violations, including failure to establish and maintain procedures for manufacturing steps performed by DRS.
The FDA also found several instances where records provided by DRS to another human tissue-recovery firm were at odds with the official death certificates that the FDA had obtained from the state.
Margaret O’K Glavin, Associate Commissioner, Office of Regulatory Affairs, says in a statement, “Patient safety is at the forefront of today’s action… 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 get tissue from human donors and send them to establishments that process the material for use in implantation or transplantation.
