Federal officials said they are investigating several funeral homes that had referred donors to a Raleigh supplier of human body parts that was recently ordered to shut down.
The Food and Drug Administration ordered Donor Referral Services and its owner, Philip Guyett of Raleigh, to cease all activity Friday after a June inspection revealed several violations "serious and widespread" enough to pose a "danger to public health."
Guyett misstated the age, cause of death and other risk factors of at least five donors he harvested for transplantation, medical research and commercial use, the agency said.
The FDA also is investigating the owners of funeral homes who referred donors to Guyett in the past year, agency spokeswoman Heidi Valetkevitch said Monday. Valetkevitch said she could not give more details during the investigation.
Guyett was not at his office Monday and could not be reached at home. His business telephone number has been temporarily disconnected.
Friday was not the first time his name has surfaced in connection with investigations of body parts. Los Angeles County prosecutors filed theft and embezzlement charges against him six years ago after alleging that he sold a cadaver that belonged to Western University of Health and Sciences in Pomona, Calif. A police raid of a warehouse he used at the time found three freezers containing humans heads and hearts.
He later pleaded not guilty, The Associated Press reported.
The latest case follows a string of malfeasance within the tissue harvesting and dismemberment trade. The FDA gets involved in cases where harvested parts are being implanted, but no federal authority monitors the industry as a whole. "There has been a total lack of accountability in the industry," said Larry Parker, president of the Cremation Society of the Carolinas, a Raleigh funeral home that had referred potential donor candidates to Guyett. Parker added that he had not been contacted by federal officials.
He said he had not seen or heard from Guyett since December, when Guyett told him he was going out of business.
Neither Guyett nor his company belong to the American Association of Tissue Banks, a group that sets strict standards for how tissue is recovered and processed, The Associated Press reported.
The company is located at 4724 Hargrove Road and maintains a separate address at 5300 Atlantic Ave., both in Raleigh.
"He's been a good tenant and we've never heard anything out of him," said Wes Learoyd, who leases a 850-square-foot office to Guyett.
Learoyd said Guyett told him he harvested primarily synthetic replacement parts from donors and refurbished and resold them to medical professionals.
Most organ and tissue research takes place at universities and is funded by the federal government, pharmaceutical companies and automakers, which use whole cadavers as crash-test dummies. Consumer products makers also use human heads and limbs to test protective gear such as helmets and braces, which they drop repeatedly with body parts inside.
Donor Referral Services harvests human cells and tissues and manufactures cellular and tissue-based products, according to the FDA's cease-and-desist order, which was hand-delivered to Guyett's office Friday. The letter indicates that an FDA official spoke to Guyett by phone that day.
Donor Referral Services cannot resume operations without FDA permission, the agency wrote in the letter. The letter says information about donors' medical records and certificates of death appeared to have been doctored.
The agency also wrote that the company failed to report that a particular donor was an intravenous drug user, and therefore a major risk for spreading diseases such as AIDS. The company also listed several donors as younger than they actually were and omitted important details about their health conditions before death, according to the FDA.
The FDA said it found no infections in people who received tissue harvested by the company.