FDA WARNING_LETTER - CMS Imaging, Inc., - December 13, 2012

During a December 11-13, 2012, inspection, the FDA determined that CMS Imaging, Inc., an assembler of diagnostic x-ray systems, violated federal regulations. The firm failed to provide manufacturer instructions/specifications for installations and documentation of adherence to these instructions during assembly or reassembly of diagnostic x-ray systems, as required by 21 CFR 1020.30(d).

Additionally, the firm failed to submit Form FDA 2579, Report of Assembly of a Diagnostic X-Ray System, to the FDA, the relevant State agency, and the purchaser within 15 days of assembly completion for multiple installations and component replacements between 2009 and 2012. This violates 21 CFR 1020.30(d)(1) and Section 538 of the Act. Specific instances include installations on 3/9/2009 and 4/24/2012, and component replacements on 9/8/2011 and 9/13/2011. The inspection also revealed 23 instances where submitted FDA 2579 forms were inaccurate or incomplete, with 10 specific examples provided.

The FDA requires a written response within 15 working days detailing corrective actions, including a Corrective Action Plan (CAP) to ensure future compliance with manufacturer specifications and