DMX-Works, Inc. – FDA EIR, May 31, 2001

An FDA inspection of VF - Works, Inc., a Palm Harbor, FL-based manufacturer of videofluoroscope systems, was conducted from May 29-31, 2001. The purpose was to evaluate the company's adherence to federal quality system regulations for medical devices. The firm produces a specialized X-ray system used to visualize bone and muscle motion, detecting conditions like whiplash. The inspection identified several significant compliance issues. A primary concern was the persistent failure to establish and maintain adequate Corrective and Preventive Action (CAPA) procedures, a deficiency also noted in a prior inspection. Management was found to have failed in ensuring an effective quality system, evidenced by the continued CAPA inadequacies, insufficient management review processes, and the absence of internal audits for over 20 months, contrary to company procedures. Furthermore, the company's design validation procedures were unclear, and Device Master Records, specifically master drawings, lacked required approval signatures and dates. In response to the FDA 483 observations, CEO/President Dr. John Postlethwaite committed to addressing all identified issues. His proposed corrective actions included signing and dating all master records, arranging necessary staff training for Quality System and Good Manufacturing Practices, and securing the services of a new quality consultant. The company was advised to submit a timely response outlining their corrective actions within 15 working days.