MANUFACTURER IMPLANTED DEVICES WITHOUT WRITTEN CONSENT, FDA SAYS
Galesburg Orthopedic Services did not obtain written consent from patients before implanting its devices, nor did it obtain FDA and institutional review board (IRB) approval before allowing patients to participate in clinical trials, the FDA said in a recent warning letter.
The FDA inspected the Galesburg, Ill., clinic in November 2005 and issued a Form 483, primarily due to poor recordkeeping and reporting. A subsequent inspection between March 20 and April 5 found similar recordkeeping issues, the FDA said in a July 6 letter. The FDA posted the letter on its website July 24.
The firm did not have signed investigator agreements from its physicians and did not report on the progress of its device study to its institutional review board or the FDA, the agency said.
Galesburg failed to ensure that its investigation of the devices was conducted in accordance with the signed agreement (the investigational plan), and any conditions imposed by the FDA or the IRB, the letter said.
Further, the FDA's letter said Galesburg did not keep accurate, complete and current records regarding the receipt and disposal of the study devices.