Inspections, Compliance, Enforcement, and Criminal Investigations
American Mobile Medical Surgical Group Inc 17-Aug-07
Department of Health and Human Services
Public Health Service
Food and Drug Administration
RETURN RECEIPT REQUESTED
August 17, 2007
Re: MQSA Inspection ID #2366980001
David A. Napier
American Mobile Medical Surgical Group Inc.
39 Tantum Ct.
Bordentown, NJ 08505
Dear Mr. Napier:
On June 11, 2007, a representative of the Food and Drug Administration (FDA) inspected your facility. This inspection revealed a serious problem involving the conduct of mammography at your facility. Under the Mammography Quality Standards Act of 1992 ("MQSA"), which is codified in Section 263b of Title 42 of the United States Code (USC), your facility must meet specific requirements to practice mammography. These requirements help protect the health of women by assuring that a facility can perform quality mammography.
The inspection revealed a violation(s) of the MQSA at your facility. These violations were noted on the MQSA Facility Inspection Report and the document "Important Information about Your MQSA Inspection" that the inspector faxed to your facility on July 5, 2007. The violations are again identified below:
Level 1: Your mobile facility performed mammography without a valid certificate on 16 distinct occasions from January 10, 2006 through April 5, 2006 and on at least 4 distinct occasions from October 10, 2006 through November 14, 2006 [see 21 CFR900.11(a)].
Level 1: Phantom quality control records were missing for all days of operation during the period of May 20, 2006 through July 10, 2006 for X-ray unit 1 in your mobile facility [see 21 CFR900.12(e)(2)].
Level 1: Processor quality control records were missing for all days of operation during the period of May20, 2006 through July 10, 2006 for processor 1 in your mobile facility [see 21 CFR 900.12(e)(1)].
Level 1: The system to communicate results is not adequate for your facility because:
There is no system in place to provide timely medical reports [see 21 CFR 900.12(c)(2)(i) and (3)(i)].
There is no system in place to provide timely lay summaries [see 21 CFR 900.12(c)(2)].
There is no system in place to communicate serious or highly suggestive cases ASAP [see 21 CFR 900.12(c)(3)(ii)].
On June 29 and July 19, 2007, we received your responses to the MQSA Facility Inspection Report. The responses were inadequate in that they failed to adequately address the inspectional observations relating to processor and phantom image quality control testing; your mammography medical outcomes audit and problems with your system to provide mammography reports and patient results letters in a timely manner, amongst other deviations.
Because the continued failure to resolve these violations maybe indicative of serious underlying problems that could compromise the quality of mammography at your facility, FDA may take additional actions, including, but not limited to, the following:
requiring your facility to undergo an Additional Mammography Review
placing your facility under a Directed Plan of Correction
charging your facility for the cost of on-site monitoring
seeking civil money penalties up to $11,000 for each failure to substantially comply with, or each day of failure to substantially comply with, MQSA standards
seeking to suspend or revoke your facility's FDA certificate
See 42 USC 263b(h)-(j) and 21 CFR900.12(j).
FDA may need to perform a Compliance Follow-up Inspection to determine that each problem at your facility has been corrected.
You should respond in writing to FDA within fifteen (15) working days from the date you received this letter. Your response should address the findings listed above and include:
1. the specific steps you have taken, or will take, to correct all of the violations noted in this letter, including projected timeframes for implementing those steps;
2. the specific steps you have taken, or will take, to prevent the recurrence of similar violations, including projected timeframes for implementing those steps;
3. Sample records that demonstrate proper record keeping procedures;
Your response to this letter should be directed to the U.S. Food and Drug Administration, Attention: Richard D. Manney, Compliance Officer at the address and telephone number listed above. If you have additional or more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Mr. Manney.
Finally, you should understand that there are many requirements pertaining to mammography. This letter pertains only to violations related to the recent inspection(s) of your facility and does not necessarily address other obligations you have under the law. You may obtain general information about all of FDA's requirements for mammography facilities by contacting the Mammography Quality Assurance Program, Food and Drug Administration, P.O. Box 6057, Columbia, MD 21045-6057 (1-800-838-7715) or through the Internet at http://www.fda.gov/cdrh/mammography/index.html.
Douglas I. Ellsworth
New Jersey District
CC: Priscilla F. Butler, M.S., FAAPM
Director, Breast Imaging Accreditation Programs
American College of Radiology
1891 Preston White Drive
Bureau of Radiation Control
Reston, Virginia 22091