FDA WARNING_LETTER - Parks Medical Electronics, Inc. - August 17, 2012

An FDA inspection conducted from July 30 to August 17, 2012, at a firm in Aloha, Oregon, manufacturing Doppler Ultrasound systems and non-invasive vascular diagnostic devices, including the Flo-Lab 2100-SX, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820). The devices are considered adulterated due to non-conformity with current good manufacturing practices. Nine distinct violations were identified. These include the failure to establish and maintain adequate procedures for design changes (21 CFR 820.30(i)), supplier control (21 CFR 820.50(a)(2)), and records of acceptable suppliers (21 CFR 820.50(a)(3)). The firm also failed to submit quality problems and corrective and preventive actions (CAPA) for management review (21 CFR 820.100(a)(7)) and lacked adequate CAPA procedures for analyzing quality data (21 CFR 820.100(a)(1)). Further deficiencies included inadequate servicing instructions (21 CFR 820.200(a)), insufficient management review of the QS (21 CFR 820.20(c)), and failure to properly appoint and document a QS management representative (21 CFR 820.20(b)(3)). Lastly, the firm failed to include primary identification labels in Device History Records (21 CFR 820.184(e)). A submitted response was deemed inadequate due to incomplete documentation. The FDA requires prompt corrective action within fifteen business days, with detailed plans and documentation, warning of potential regulatory actions such as seizure, injunction, and denial of premarket approvals or Certificates to Foreign Governments if violations are not corrected.