DMX-Works, Inc. – FDA Warning Letter, Jul 1, 2012

On October 26, 2012, the FDA issued a Warning Letter to DMX-Works, Inc. following a June 4-7, 2012 inspection of their Palm Harbor, FL facility, which manufactures Digital Motion X-ray fluoroscopic systems. The inspection found these devices to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and Electronic Product Radiation Control (EPRC) violations (21 U.S.C. § 360oo and 21 CFR Subchapter J).

Key QS violations included: 1. Failure to maintain an adequate Device Master Record (DMR) (21 CFR 820.181). While a CAPA was initiated, the adequacy of the response was noted. 2. Failure to document acceptance activities (21 CFR 820.80(e)), with the response deemed inadequate as existing procedures were not followed and training records were missing. 3. Failure to establish and maintain adequate procedures for changes to specifications (21 CFR 820.70(b)), with the response inadequate due to a systemic lack of understanding of design control. 4. Failure to establish and maintain adequate supplier requirements (21 CFR 820.50(a)),