DEVICEMAKER WARNED FOR NOT CHANGING FAULTY PRODUCTS

Trionix Research Laboratory neglected to perform device change procedures on a faulty product and did not inform the FDA of the malfunction, a recent agency warning letter said.

Because of current good manufacturing practice violations found during the inspection July 25Aug. 9, the company's nuclear imaging devices are misbranded and adulterated, the Nov. 21 letter said. The letter was posted on the FDA website earlier this month.

Several of the violations stemmed from a complaint the firm received April 22, 2002, that a detector head on a Biad nuclear imaging system had fallen and trapped a patient. Trionix determined why the device broke and said it would notify all customers of a design change for the Biad devices beginning in July 2002. According to the FDA, the design change of these devices has not yet been performed.

During the investigation, Trionix informed the FDA investigator that a recall of all Biad systems in use will begin in January, the letter said. The FDA has requested an update on the status of that action.

The warning letter also faulted Trionix for not submitting a written report to the FDA regarding the change to the Biad device, for not documenting formal approval of the change and for not using design controls or verification protocols.

A company spokesperson said Trionix has responded to the warning letter and is carrying out a plan to address the violations.

The warning letter can be viewed at www.fda.gov/foi/warning_letters/g6139d.pdf (http://www.fda.gov/foi/warning_letters/g6139d.pdf).