FDA WARNING_LETTER - Protech Professional Products, Inc. - December 13, 2013

An FDA inspection of ProTech Professional Products, Inc. on December 11-13, 2013, revealed significant violations regarding their ProTech Plus Self Cure Hard Reline and Repair Acrylic Powder and Liquid devices. The firm was found to have made unapproved modifications to the denture base resins after receiving 510(k) clearances (K983547 and K925062).

Specifically, the firm changed the manufacturing process from a "(b)(4)" process to a "(b)(4)" process, which uses different component ingredients than those listed in the 510(k) clearance. Additionally, the firm uses Pigment Red 187, Pigment Yellow 180, and Pigment Red 149 as coloring components, whereas the 510(k) clearance lists FD&C Red 40.

These modifications render the devices adulterated under section 501(f)(1)(B) of the Act, as the firm lacks an approved premarket approval (PMA) or investigational device exemption. The devices are also misbranded under section 502(o) because the required notice of these modifications was not provided to the FDA as per section 510(k) and 21 CFR 807.81(a)(3)(i).

Furthermore, the inspection identified several quality system deficiencies, including: