FDA WARNING_LETTER - Interlectric Corporation - December 06, 2011

An FDA inspection of Interlectric Corp. on November 15 and December 6, 2011, identified significant violations regarding their RV620 linear fluorescent “red” lamp device. The FDA determined the RV620 is a Class II medical device requiring premarket notification (510(k)) clearance, a fact communicated to the firm on August 18, 2011. Despite this, Interlectric Corp. continued to manufacture and distribute the device without the necessary marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act. Consequently, the RV620 device is deemed adulterated under section 501(f)(1)(B) for lacking an approved premarket approval (PMA) or investigational device exemption (IDE) application. It is also misbranded under section 502(o) due to the firm's failure to submit a 510(k) premarket notification. The firm's December 14, 2011, response was inadequate, as it indicated continued marketing of the device and failed to propose corrective actions for already distributed lamps with promotional literature. Interlectric Corp. must promptly correct these violations and notify the FDA within fifteen business days with a comprehensive plan, including documentation and a timetable for systemic corrective actions. Failure to comply may lead to regulatory actions such as seizure, injunction, or civil money penalties, and could impact federal contract awards.