FDA Closes North Carolina Tissue Recovery Firm
Firm was deficient in manufacturing, donor screening and record-keeping
TUESDAY, Aug. 22 (HealthDay News) -- The U.S. Food and Drug Administration has ordered human tissue-recovery firm Donor Referral Services (DRS), of Raleigh, N.C., and its owner, Philip Guyett, to cease operations with immediate effect.
These measures were imposed in the wake of an FDA inspection that found serious deficiencies not only in the company's manufacturing processes but also in donor screening and record keeping. The company was ordered to retain human cells, tissues and other related products.
"While most tissues are obtained and manufactured using appropriate protections, some operators are not following acceptable practices," Jesse L. Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "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 FDA inspection of DRS found that the firm failed to put in place procedures for manufacturing, and also uncovered instances of records that DRS provided to another tissue recovery firm did not match the official death certificates obtained by the FDA.