FDA WARNING_LETTER - Acacia Engineered Products LLC - October 17, 2007

On October 11 and 17, 2007, an FDA inspection of Acacia Engineered Products, LLC, located in Franklin, Tennessee, revealed that the firm manufactures the IsoBalance device. The IsoBalance is considered a device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The inspection found the IsoBalance to be adulterated under Section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) application or an approved investigational device exemption (IDE). The device is also misbranded under Section 502(o) of the Act for several reasons: the firm failed to notify FDA of its intent to introduce the device into commercial distribution as required by Section 510(k), the establishment is not duly registered under Section 510, and the device was not included in a list required by Section 510(j).

Furthermore, the device is adulterated under Section 501(h) of the Act because the manufacturing, packing, storage, or installation methods, facilities, or controls do not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR 820). The firm failed to establish or implement the QS procedures required by Part 820.

The FDA requires prompt corrective action to address these violations