Kral X-ray Inc. 2/21/13
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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 21, 2013
John F. Kral, Owner
Marla A. Kral, Co-Owner
Kral X-Ray, Inc.
3145 Friendship Road
Buford, GA 30519
Dear Mr. and Mrs. Kral:
During an inspection of your firm located at 3145 Friendship Road in Buford, GA, conducted on January 15-17, 2013, 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.
You must submit a FORM FDA 2579 (FDA 2579 form), Report of Assembly of a Diagnostic X-Ray System, 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 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 file the FDA 2579 forms as required.
| (b)(4)|| (b)(4)|| Installation Date: 06/01/2012|
| (b)(4)|| (b)(4)|| Installation Date: 09/10/2012|
| (b)(4)|| (b)(4) || Installation Date: 03/01/2011|
| (b)(4)|| (b)(4)|| Installation Date: 04/04/2011|
| (b)(4)|| (b)(4)|| Installation Date: 08/01/2011|
| (b)(4)|| (b)(4)|| Installation Date: 11/07/2011|
| (b)(4)|| (b)(4)|| Installation Date: 07/02/2010|
| (b)(4)|| (b)(4)|| Installation Date: 04/01/2010|
| (b)(4)|| (b)(4)|| Installation Date: 02/20/2009|
| (b)(4)|| (b)(4)|| Installation Date: 07/21/2009|
| (b)(4)|| (b)(4)|| Installation Date: 12/08/2008|
Additionally, you are required to file a FDA 2579 form with the FDA, the appropriate State agency responsible for radiation protection, and the purchaser, within 15 days following the completion of the assembly. During a review of your FDA 2579 forms, our investigator identified locations where you assembled diagnostic x-ray systems or replaced certified components, but failed to provide the purchaser, and the appropriate State agency with copies of the FDA 2579 forms as required. The following were among those locations identified:
|D1088105|| (b)(4)|| (b)(4)|| Installation Date: 03/06/12|
|D1088103|| (b)(4)|| (b)(4)|| Installation Date: 05/18/09|
|D1088113|| (b)(4)|| (b)(4)|| Installation Date: 01/07/09|
|D1087941|| (b)(4)|| (b)(4)|| Installation Date: 05/02/07|
Additionally, our investigator reviewed your FDA 2579 forms and identified locations where 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 two locations were among those found incomplete during the inspection:
|D1087987||Southern Ortho Specialists ||Fayetteville, GA || Installation Date: No date|
|D1088107||Ortho Atlanta||Newnan, GA|| Installation Date: 01/29/12|
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.
We received your written response to the FORM FDA 483, Inspectional Observations, and it appears to adequately address most of the violations noted. Some concerns remain, however, regarding the sustainability of your corrective actions, due to your firm’s history of noncompliance as evidence by the issuance of a warning letter to you in 2003 for similar violations. Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the preventive steps you have taken or plan to take to ensure that violations, such as those found during the recent and previous inspections, will not occur in the future. If you are unable to complete the preventive action plan within fifteen (15) working days, identify the reason for the delay and the timeframe within which you plan to complete the request. 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