FDA WARNING_LETTER - Advantageous Md Llc - September 13, 2011

On October 4, 2011, the FDA issued a Warning Letter to Advantageous MD, LLC, following an inspection on September 7 and 13, 2011. The inspection determined that the firm, a specification developer of the AMD 6605 TENS/NMES Stimulator, ASD 150 Cervical Traction Collar, and ASD 550 Lumbar Traction Belt, was in violation of the Federal Food, Drug, and Cosmetic Act.

The devices were found to be adulterated under section 501(h) of the Act, as their manufacturing, packing, storage, or installation methods and controls did not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). Significant violations included: - Failure to establish procedures for design control, document control, finished device acceptance, control of nonconforming product, and Medical Device Reporting (MDR). No record of design activities for the AMD 6605 TENS/NMES Stimulator was found. - Failure to maintain complaint files (21 CFR 820.198). The firm did not consider multiple events as complaints, including skin irritation/burns from the AMD 6605, returned "broken" devices, and issues with device functionality and components. The firm's "Policy 1.4. Complaint