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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Community Radiology Associates 22-Feb-06

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

Public Health Service
Food and Drug Administration

 

Central Region
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone:(410) 779-5454
FAX: (410) 779-5703



FEI:1000512554

WARNING LETTER

February 22, 2006

VIA Certified Mail
RETURN RECEIPT REQUESTED

Mr. Gene Perry
Director of Operations
Community Radiology Associates
18111 Prince Philip Dr.
Ste. T-20
Olney, MD 20832

Dear Mr. Perry:

On 01/25/2007, 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 left with Robin Laura at your facility at the close of the inspection on 01/25/2007. The violation(s) is/are again identified below:

Level 2: Failed to produce documents verifying that the radiologic technologist [redacted] (11.5 CEU's in 36 months) met the continuing education requirement of having taught or completed at least 15 continuing education units in mammography in 36 months (REPEAT). [21 CFR Part 900.12(a)(2)(iii)]

Level 2: The measured fog density is equal to 0.16 for darkroom at site Community Radiology Associates (REPEAT). [21 CFR Part 900.12(e)(4)(i)]

Level 3: The screen-film contact QC is not adequate for site Community Radiology Associates because (REPEAT): - Corrective action (before using the failed cassette(s) for further exams) was not documented at least once. [21 CFR Part 900.12(e)(4)(ii)]

Level 3: The required personnel qualification documents were not available during the inspection (REPEAT). [21 CFR Part 900.12(a)(4)]

Because the continued failure to resolve this (these) violation(s) may be 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 $10,000 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

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;

Please submit your response to this letter to:

Randy F. Pack, Compliance Officer
6000 Metro Drive
Suite 101
Baltimore, MD 21215

Please send a copy of your response to:

Bob Nwadije
Maryland Department of the Environment
Radiation Machines Division, ARMA-RHP
1880 Washington Boulevard
Suite 750
Baltimore, MD 21230

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.

If you have additional or more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Randy F. Pack at 410-779-5417.

Sincerely yours,

Evelyn Bonnin
District Director