CMS Imaging, Inc., 2/6/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Atlanta District Office|
60 Eighth Street N.E.
Atlanta, GA 30309
February 6, 2013
John C. Sloan, President/CEO
CMS Imaging, Inc.
4050 Azalea Drive
North Charleston, SC 29405
Dear Mr. Sloan:
During an inspection of your firm located at 4050 Azalea Drive in North Charleston, SC, conducted on December 11-13, 2012, an investigator of the U. S. Food and Drug Administration (FDA) determined that your firm is an assembler of diagnostic x-ray systems, as defined by Title 21, Code of Federal Regulations (21 CFR) 1020.30(b) [21 CFR 1020.30(b)]. Diagnostic x-ray systems are devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
The responsibilities of an assembler of diagnostic x-ray systems may be found at 21 CFR 1020.30(d). As an assembler of diagnostic x-ray systems, you are required to assemble, install, adjust, and test the certified components according to the instructions of their respective manufacturers. However, during our inspection, your firm was unable to provide our investigator with the manufacturers’ instructions and/or specifications for installations, along with documentation that your firm followed those instructions/specifications, during assembly or reassembly of the diagnostic x-ray systems installed.
Additionally, you are required to file a FORM FDA 2579 (FDA 2579 form), Report of Assembly of a Diagnostic X-Ray System, with the FDA, the appropriate State agency responsible for radiation protection, and the purchaser, within 15 days following the completion of the assembly. You must submit an FDA 2579 form for each certified diagnostic x-ray system you assemble, to comply with 21 CFR 1020.30(d)(1). Failure to file a FDA 2579 form is a violation of the Section 538 of Subchapter C – Electronic Radiation Control (formerly the Radiation Control for Health and Safety Act of 1968) of the Act. Our investigator identified the following locations where you assembled diagnostic x-ray systems or replaced certified components, but failed to submit and provide the purchaser, the FDA, and the appropriate State agency with copies of the FDA 2579 forms as required.
- On 3/9/2009, your firm installed a diagnostic x-ray system at (b)(4).
- On 9/8/2011, your firm replaced a certified component in an existing system at (b)(4).
- On 9/13/2011, your firm replaced a certified component in an existing system at (b)(4).
- On 4/24/2012, your firm installed a diagnostic x-ray system at (b)(4) on 04/24/2012.
Additionally, our investigator reviewed your FDA 2579 forms and identified 23 specific locations in which your firm assembled diagnostic x-ray systems or replaced certified components, but failed ensure that the forms filed were both accurate and complete. The FDA 2579 forms for the following locations were among those found incomplete:
D537780 (b)(4) (b)(4) Installation Date: 11/18/10
D1409537 (b)(4) (b)(4) Installation Date: 09/26/12
D537775 (b)(4) (b)(4) Installation Date: 02/24/10
D537689 (b)(4) (b)(4) Installation Date: 11/03/08
D1294535 (b)(4) (b)(4) Installation Date: 07/23/08
D1353306 (b)(4) (b)(4) Installation Date: 08/20/07
D1353331 (b)(4) (b)(4) Installation Date: 01/25/08
D1353372 (b)(4) (b)(4) Installation Date: 04/24/08
D1409510 (b)(4) (b)(4) Installation Date: 11/01/10
D1750000 (b)(4) (b)(4) Installation Date: 09/26/12
This letter is not intended to be an all-inclusive list of violations that may exist with respect to your firm. You are responsible for ensuring that your firm is operating in compliance with the Act and all applicable regulations. Failure to promptly correct these violations can result in regulatory action being initiated by FDA without further notice. These actions include seizure, injunction, and the imposition of civil penalties as provided for in Section 538 of the Act. Persons violating Section 538 of the Act are subject to civil penalties of up to $1,000 per violation and up to a maximum of $300,000.
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or plan to take to correct these current violations and to prevent future ones. You should provide this office with an appropriate Corrective Action Plan (CAP) to assure that all future assemblies performed by your firm will comply with each manufacturer’s specifications, for each type of system or certified component assembled, and comply to the performance standard outlined in 21 CFR Subchapter J. We are requesting documentation that the installations identified in the letter are in compliance with applicable sections of 21 CFR 1020 related to the performance standard for diagnostic x-ray equipment. Please provide evidence that you have completed and submitted FDA 2579 forms to the pertinent individuals listed in this letter and for any additional installations you identify for which forms have not been filed. In your response, please include the timeframe within which the correction actions will be completed and documentation that will effectively assist us in evaluating the adequacy of the corrections. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the timeframe within which you plan to complete the corrections. Your written response should be sent to the U.S. Food and Drug Administration, Attn: Lakisha N. Morton, Compliance Officer, at the address noted in the letterhead. If you have questions, please contact Mrs. Morton at 404-253-1285.
John R. Gridley