innovations for access, inc., – FDA Warning Letter, Oct 5, 2007

An FDA inspection of Dr. Geary's firm (1815 NW 169th Place, Suite 6030, Beaverton, Oregon) on September 25 and October 5, 2007, revealed significant violations regarding the HemoBand-1M (sterilized) and HemoBand-NS (unsterilized) devices.

The unsterilized HemoBand-NS is adulterated under section 501(f)(1)(B) of the Act because it lacks premarket approval (PMA) or an investigational device exemption (IDE); the firm's 510(k) clearance (K920614) only covers the sterile version. It is also misbranded under section 502(o) for failure to notify the FDA of intent to introduce the device into commercial distribution.

The sterilized HemoBand-1M is misbranded under section 502(f)(1) as its current labeling lacks a required warning statement instructing users to listen for bruit, a caution previously agreed upon during the 510(k) review.

Both devices are 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 violations include: 1. Failure to establish