FDAnews
www.fdanews.com/articles/90193-fda-warns-adjustable-bed-company-for-ignoring-complaints

FDA WARNS ADJUSTABLE BED COMPANY FOR IGNORING COMPLAINTS

February 7, 2007

The FDA sent the Craftmatic Organization a warning letter for failing to handle and report product complaints, but the company said it should not have received the letter because it did not manufacture the devices.

Following inspections May 24-June 13, 2006, Craftmatic's therapeutic adjustable beds were found to be adulterated, the warning letter said.

But Craftmatic responded that it should not be faulted for problems with the beds because it is a "relabler" or "distributor" of the devices and not a manufacturer, according to the letter.

However, the FDA's definition of a manufacturer includes any person who "changes the labeling of a device in furtherance of the distribution of the device from the original place of manufacture."

The firm lacked a formal written procedure to process product complaints, and had not assigned an individual who would be responsible for investigating complaints, the FDA said. Additionally, the company did not have a formal procedure to investigate product nonconformities.

(http://www.fdanews.com/ddl/34_6/)