Branan Medical Corp. Inc. – FDA Warning Letter, Oct 9, 2009

On December 28, 2009, the FDA issued a Warning Letter to Branan Medical Corp., Inc. following an inspection from July 15 to October 9, 2009. The inspection revealed that the firm's in-vitro diagnostic (IVD) drug of abuse kits, specifically Oratect III, OratectPlus, Oratect XP, and Monitect X04-SC10, are adulterated because they lack approved pre-market approval (PMA) or investigational device exemption (IDE) applications. These devices are also misbranded for failure to provide 510(k) notification for modifications.

The inspection also found that the firm's devices are adulterated under 21 CFR Part 820 (Quality System Regulation). Deficiencies include: 1. Failure to adequately establish and maintain procedures for validating device design, including insufficient stability testing data for Fastect II and QuickTox Multi Drug Dipcard, and unsupported accuracy/precision claims. 2. Failure to adequately establish and maintain procedures for design change identification, documentation, validation, and approval, with no verification/validation data provided for several significant changes to Monitect, QuickTox, and Fastect II devices. 3. Failure to adequately define and document design output, as seen with the CLIA Waive Fastect II device. 4. Failure to conduct formal documented design