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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Atlanta Dental Supply Company, Inc 9/5/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309
Telephone: 404-253-1161
FAX: 404-253-1202

September 5, 2012
 

 

VIA UPS

Gary E. Kirkus, CEO/President
Atlanta Dental Supply Company, Inc.
1650 Satellite Boulevard
Duluth, GA 30097

Warning Letter
(12-ATL-19)
 

Dear Mr. Kirkus:
 

During an inspection of your firm located at 1650 Satellite Boulevard, Duluth, GA, conducted June 19-21, 2012, an investigator of the Food and Drug Administration (FDA) determined that your firm is an assembler of diagnostic x-ray equipment as defined under Title 21 Code of Federal Regulations (CFR) 1020.30(b). At that time, our investigator explained to you your responsibility to file a Report of Assembly of a Diagnostic X-Ray System, FORM FDA 2579, for each certified diagnostic x-ray system you assemble. It was also noted that your firm, since inception, has failed to follow the manufacturer's instructions and/or specifications for installation during assembly or reassembly of certified diagnostic
x-ray systems as required under 21 CFR 1020.30. These installations took place in the states of Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.

We have identified these specific locations as follows for which your assembly of certified diagnostic xray equipment was not reported in accordance with 21 CFR 1020.30(d)(l) in that you failed to correctly complete :

1.    (b)(4) Installation Date 09/15/2009
2.    (b)(4) Installation Date 07/16/2010
3.    (b)(4) Installation Date 01/25/2012
4.    (b)(4) Installation Date 05/02/11
5.    (b)(4) Installation Date 05/24/11
6.    (b)(4) Installation Date 10/28/10
7.    (b)(4) Installation Date 11/15/10
8.    (b)(4) Installation Date 07/17/2010
9     (b)(4) Installation Date 01/15/2010
10.  (b)(4) Installation Date 01/08/10
11.  (b)(4) Installation Date 12/31/09
12.  (b)(4) Installation Date 12/04/09
13.  (b)(4) Installation Date 12/04/09
14.  (b)(4) Installation Date 10/15/09
15.  (b)(4) Installation Date 05/29/09
16.  (b)(4) Installation Date 05/18/09
17.  (b)(4) Installation Date 04/13/09
18.  (b)(4) Installation Date 05/23/12
19.  (b)(4) Installation Date 05/08/12
20.  (b)(4) Installation Date 10/12/11 
21.  (b)(4) Installation Date 05/02/11
22.  (b)(4) Installation Date 05/02/11
23.  (b)(4) Installation Date 05/02/11
24.  (b)(4) Installation Date 07/02/10
25.  (b)(4) Installation Date 05/07/10 
26.  (b)(4) Installation Date 05/25/10
27.  (b)(4) Installation Date 1/06/09 
28.  (b)(4) Installation Date 10/15/09
29.  (b)(4) Installation Date 12/23/09
30.  (b)(4) Installation Date 03/21/07

In addition to the above listed sites for which your firm failed to correctly complete reports of installations of certified x-ray equipment, the investigator also noted that your firm failed to provide the purchaser and submit a of for three diagnostic x-ray assemblies. These assemblies were performed a (b)(4).  Records detailing these installations at your consisted of the three Report of Assembly of a Diagnostic X-Ray System, FORM FDA 2579 numbers 01148784, D1148796, and D1148687 which were noted to be copies intended for the purchaser and state as contained in your firm's 2008 folders. A copy of the Report of Assembly is to be provided both to the purchaser and appropriate state agency as outlined in 21 CFR 1020.30(d).

The above assemblies may not be an all-inclusive list for all systems you have installed without submitting the required Report of Assembly.

We are in receipt of your response letter dated July 9, 2012. Your response is inadequate in that it does not identify corrective and preventive actions your firm is taking to prevent the recurrence of similar violations.

You should review all installation records, invoices, etc. to determine the total number of installations performed by your firm during the last five years. We request that you provide evidence that the above installations, as well as the installations which you identify through your review of records, are in compliance with applicable portions of the Performance Standard for Diagnostic X-Ray Equipment 21 CFR Sections 1020.30-32. Additionally, 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 certified component or system assembled and comply to the performance standard as outlined under 21 CFR Chapter 1 Subchapter J - Radiological Health.

Accurate and complete Reports of Assembly of Diagnostic X-Ray System, FORM FDA-2579s, are required to be submitted to FDA, the appropriate State Radiation Control Program, and the purchaser within 15 days following the completion of assembly pursuant to 21 CFR 1020.30(d). As part of your required corrective action under 21 CFR 1004, within 15 days you must complete FORM FDA-2579 and submit copies to the above indicated individuals for each installation listed above and any additional installation you discover in your review of records. Failure to file a Report of Assembly of a Diagnostic X-Ray System, FORM FDA-2579, is a violation of the Federal Food, Drug, and Cosmetic Act (the Act), Section 538 of Subchapter C-Electronic Product Radiation Control (formerly the Radiation Control for Health and Safety Act of 1968).

Failure to promptly correct the above violations can result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include seizure and/or injunction and/or the imposition of civil penalties. Persons violating Section 538 of the Act are subject to civil penalties up to $1,000 per violation and up to a maximum of $300,000. In addition to providing a FORM FDA-2579 for each of the above listed installations, you should notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be sent to Derek Price, Compliance Officer, 60 Eighth Street NE., Atlanta, Ga 30309. If you have any questions, you may contact Mr. Price at (404) 253-2277.

Sincerely,

/s/

John R. Gridley
District Director
Atlanta District Office
 

Cc: Ms. Sheela Puthumana
     Healthcare Facility Regulations
     GA Department of Community Health
     2 Peachtree Street, NW Floor # 31
     Atlanta, GA 30303-3167