FDA WARNING_LETTER - Subcon Manufacturing Corporation - January 31, 2012

An FDA inspection of Subcon Manufacturing Corporation, a contract manufacturer of LED skincare and teeth whitening systems, was conducted from January 10-31, 2012. The inspection revealed significant violations regarding the Evado Model 1029 and Revitalight Skin Care System Model SSE-1000, which are classified as medical devices. The Evado Model 1029 was found to be adulterated under 21 U.S.C. § 351(f)(1)(B) due to the lack of an approved premarket approval (PMA) or investigational device exemption (IDE). It was also misbranded under 21 U.S.C. § 352(o) and 21 CFR 807.81(a)(3)(ii) for introducing the device with major changes to its intended use without submitting a new 510(k) premarket notification, specifically promoting new indications beyond its original clearance. Similarly, the Revitalight Skin Care System Model SSE-1000 was deemed adulterated for lacking PMA/IDE approval and misbranded under 21 U.S.C. § 352(o) and 21 CFR 807.81(a)(3)(i) for failing to notify FDA of device modifications, such as combining red and blue light for acne treatment, which requires a new premarket submission. Subcon Manufacturing Corporation is required to immediately cease activities leading to the misbranding or adulteration of these devices. The firm must provide a written response within fifteen working days detailing corrective actions, prevention plans, and a timetable for completion. Failure to comply may result in regulatory actions including seizure, injunction, or civil money penalties, and may impact federal contract awards.