Paragon Dx, LLC – FDA Warning Letter, Aug 19, 2009

The FDA issued a Warning Letter to Paragon Dx, LLC following an inspection from August 10-19, 2009, concerning their CYP2C9 and VKORC1 ASR Probe Mix devices. The inspection revealed that these devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because the firm lacks approved applications for premarket approval (PMA) or investigational device exemption (IDE) as required by sections 515(a) and 520(g) of the Act, respectively. Additionally, the devices are misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), due to the firm's failure to submit a 510(k) premarket notification as required by section 510(k) of the Act. The FDA clarified that the firm's products do not meet the definition of an Analyte Specific Reagent (ASR) under 21 CFR 864.4020(a) because they detect multiple genotypes, not an individual substance, and ASRs are restricted from performance claims. Paragon Dx must take prompt corrective action and respond within fifteen working days, detailing steps taken, prevention plans, and a timetable for completion. Failure to comply may lead to regulatory actions such as seizure, injunction, or civil money penalties, and could impact federal contract awards. The firm is responsible for investigating root causes and ensuring overall compliance.