FDA WARNING_LETTER - VIBE Technologies, LLC - November 16, 2007

On November 5-16, 2007, an FDA inspection of VIBE Technologies, LLC, revealed that their V.I.B.E. Machine, a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act, was being sold without required marketing approval or clearance. This constitutes adulteration under section 501(f)(1)(B) of the Act, as no approved premarket approval (PMA) or investigational device exemption (IDE) application was in effect.

The device was also misbranded under section 502(o) because the firm was not duly registered, the device was not listed as required, and no 510(k) notice was provided. Furthermore, the device was adulterated under section 501(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Specific QS violations included: 1. Failure to establish and maintain design control procedures (21 CFR 820.30(a)). 2. Failure to establish and maintain corrective and preventive action procedures (21 CFR 820.100(a)). 3. Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a)). 4.