PHILIPS CONTINUES DISCUSSIONS WITH FDA OVER AED WARNING LETTER

Philips Medical Systems is continuing discussions with the FDA over the company's alleged deviations from current good manufacturing practices related to the production of its automated external defibrillators (AEDs), the firm said.

After inspections Aug. 15 to Sept. 14, 2006, the agency issued a Form 483 and followed up with a Jan. 29 warning letter, which was posted on the agency website March 1.

The letter cited the company for failing to "establish and maintain procedures adequate for implementing corrective and preventive actions" related to intermittent on/off and shock switch failures for AED models FR2 and FR2+. The FDA said the failures were related to wash water contamination on the printed circuit board assemblies (PCBAs) used for the switches.

The FDA said Philips was accepting PCBAs from unapproved suppliers. Although the assemblies originated from approved sources and the company updated procurement procedures, "no system of corrective actions was submitted with regards to a review of approved suppliers versus supplied product, and no preventive action was addressed," the warning letter said.

Philip's FR2 and FR2+ AEDs were "misbranded" because the firm did not submit a written report of internal corrective action to prevent contaminated switches from being distributed, according to the FDA.

Philips met with CDRH staff Dec. 7, 2006, to discuss the agency's concerns. The firm said that it initiated a "voluntary product correction" of approximately 2,000 units in December following roughly nine field reports of buttons sticking.

The letter can be accessed at www.fda.gov/foi/warning_letters/g6238d.pdf ( http://www.fda.gov/foi/warning_letters/g6238d.pdf ).

( http://www.fdanews.com/ddl/34_11/ )