Health officials ordered a Raleigh company that collected human body parts for transplant to shut down Friday after inspectors found violations that posed a threat to human health.
The Food and Drug Administration said it ordered Donor Referral Services to cease all manufacturing and to retain all cadaver tissues, following June inspections. The company collected tissue for other firms that later processed it for transplantation.
The inspections found "serious deficiencies" in how the company screened donors and kept records, the FDA said. The FDA said it does not know of any cases of infection in people who received tissue harvested by the company.
All tissue products the company took from cadavers have been recalled, although some already have been transplanted, FDA spokesman Paul Richards said. It wasn't immediately clear how many people received tissue harvested by the company.
The FDA thinks the risk of infection is low, but the actual risk is unknown, Richards said. Patients with questions should contact their doctors, he said.
In the case of at least five cadavers, the company and its owner, Philip Guyett, altered paperwork on the health history and age of those donors, the FDA said. For one, Guyett listed in paperwork various reasons for the death of the donor but failed to log correctly that the person had died of cancer, with intravenous drug use a contributing factor, the FDA said. IV drug use is associated with elevated risk for diseases such as HIV/AIDS and hepatitis.
"Allowing the firm to continue to manufacture would present a danger to public health by increasing the risk of communicable disease transmission," said Margaret O'K. Glavin, associate commissioner of the FDA's office of regulatory affairs.
For five years in the 1990s, a Philip J. Guyett Jr. ran the willed body program at an osteopathic college in Pomona, Calif. He was arrested in 1999 in connection with selling a cadaver and keeping the $1,100 payment. At that time, police raided a warehouse he used and found three freezers containing human heads and hearts. He later pleaded not guilty.
That Guyett later incorporated a Donor Referral Services Inc. in Las Vegas. It wasn't clear whether he is the same person involved in Friday's FDA action.
The action comes as the tissue industry struggles to recover from the biggest scandal in its history, involving a now-defunct New Jersey company accused of plundering corpses for body parts without family members' permission.