FDA 483 - Interlectric Corporation - December 06, 2011

An FDA inspection of Interlectric Corporation, a device manufacturer, revealed that the firm has been manufacturing and marketing a red lamp product (model RV620) for red light therapy since 2008. The company failed to obtain marketing approval or clearance from the FDA for this product prior to its sale and has not requested it to date. This indicates a significant regulatory non-compliance regarding device marketing.