FDA WARNING_LETTER - Suarez Corporation Industries, Inc. - March 24, 2008

On March 4-24, 2008, an FDA inspection of Suarez Corporation Industries, Inc. dba Biotech Research in Canton, Ohio, identified significant violations for its PainNOT Infrared Heating Pads, Foot Choice Infrared Heat Vibrating Massager, ThermotexTM TTS Infrared Heating Pads (devices), and PainNOT Patch (drug).

The devices were deemed adulterated because the firm lacked premarket approval (PMA) or investigational device exemption (IDE) applications. They were also misbranded for failure to submit 510(k) premarket notifications and for failing to furnish information required by Medical Device Reporting (MDR) regulations (21 CFR Part 803). Specific MDR violations included failure to submit 30-day MDRs for serious injuries (e.g., third-degree burns, second-degree burns, severe burns requiring hospitalization) and failure to develop written MDR procedures. The Foot Choice Infrared Heat Massager was also misbranded for failing to report a correction and removal action (21 CFR Part 806) related to high temperature settings causing burns.

Furthermore, the devices were adulterated under Quality System (QS) regulation (21 CFR Part 820) for failing to establish corrective and preventive action procedures, identify actions to prevent recurrence of nonconforming products (e.g., not performing a health hazard evaluation for reworked devices), establish complaint handling procedures, and investigate numerous complaints of burns and burning