FDA WARNING_LETTER - Galloway Technologies, L.C. - March 02, 2011

On August 25, 2011, the FDA issued a Warning Letter to Galloway Technologies, LLC, following an inspection from February 28 to March 2, 2011. The inspection revealed that their Asyra Galvanic Skin Response Measurement devices are adulterated and misbranded.

The devices are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods and controls do not conform to Quality System (QS) regulation (21 CFR Part 820). Violations include: - Failure to establish and maintain procedures for corrective and preventive actions (21 CFR 820.100(a) and (b)). - Failure to maintain complaint files and establish complaint handling procedures (21 CFR 820.198(a)). - Failure to control nonconforming products (21 CFR 820.90(a)). - Failure to maintain adequate Device Master Records (DMRs) (21 CFR 820.181). - Failure to establish and maintain design control procedures, including Design History Files, design plans, input/output, reviews, verification/validation, risk analysis, and change control (21 CFR 820.30(a)). - Failure to develop, conduct, control, and monitor production processes (21 CFR