The Center for Devices and Radiological Health (CDRH), Office of Compliance, Division of Enforcement I, Diagnostic Devices Branch has reviewed the January/February 1999 Establishment Inspection Report of your firm, and the Form FDA 483 dated February 5, 1991, that was issued to you at the close of the FDA inspection. They also reviewed your product catalog. Based on their review your firm is in violation of Section 538 of Subchapter C-Electronic Product Radiation Control (EPRC) of Chapter V of the Act. [Formerly the Radiation Control for Health and Safety Act (RCHSA) of 1968] Under separate cover, the CDRH will contact you directly to address the EPRC violations.
