FDA Shuts Down N.C. Human Tissue Manufacturing Plant

RALEIGH, N.C. - The FDA has ordered Donor Referral Services (DRS), a human tissue-recovery firm, to immediately cease all manufacturing operations, after an inspection found serious deficiencies in its manufacturing practices.

On Aug. 18, the FDA ordered DRS and its owner, Philip Guyett, to cease operations and retain all human cells, tissues, and cellular and tissue-based products (HCT/Ps). The FDA said deficiencies included the failure to establish and maintain procedures for manufacturing steps performed by DRS. The agency said it also found several instances where records provided by DRS to another HCT/P establishment differed from the official death certificates the …