Erchonia Corporation – FDA Warning Letter, Nov 24, 2009

An FDA inspection of Erchonia Corporation in McKinney, TX, from November 17-24, 2009, revealed significant violations concerning their Zerona MLS laser scanner, classified as a medical device. The device was found adulterated for lacking an approved premarket approval (PMA) or investigational device exemption (IDE) application (21 U.S.C. § 351(f)(1)(B), § 360e(a), § 360j(g)). It was also misbranded due to the firm's failure to submit a 510(k) premarket notification (21 U.S.C. § 352(o), § 360(k)). Furthermore, Erchonia promoted new intended uses for the device, such as treating Parkinson's, reducing LDL, and suppressing appetite, via press releases without submitting the required premarket notification for these major changes (21 C.F.R. § 807.81(a)(3)(ii)).

Additionally, the inspection identified numerous nonconformances with the Quality System (QS) regulation (21 CFR Part 820). These included failures in establishing and maintaining adequate procedures for corrective and preventive actions, complaint handling, computer software validation, design change control, design validation and risk analysis, incoming product acceptance, nonconforming product control, sampling methods, and personnel training. The firm's initial responses to the FDA 483 observations were deemed inadequate. Erchonia must promptly correct these violations and provide a written response within 15 working days detailing corrective actions, prevention plans, and timelines. Failure to comply could result in regulatory actions like seizure, injunction, civil money penalties, impact on federal contracts, and denial of PMA applications or Certificates to Foreign Governments.