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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sacramento Radiology Medical Group, Inc. 10-May-07

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

Public Health Service
Food and Drug Administration

 

San Francisco District
143 1 Harbor Bay Parkway
Alameda. CA 94602-7070
Telephone: 610/337-6700


 

WARNING LETTER

May 10, 2007

Via FEDEX

Re: MQSA Inspection ID # 1054450012
FEI# 1000523874

Dr. Paul M. Parsons
Sacramento Radiology Medical Group, Inc.
7601 Hospital Drive, Suite 100
Sacramento, CA 95823

Dear Dr. Parsons:

On October 5, 2006, a representative of the State of California, acting on behalf 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 of the MQSA at your facility. This violation was noted on the MQSA Facility Inspection Report and the document "Important Information about Your MQSA Inspection" that the inspector mailed to your facility on October 10, 2006. The violation is again identified below.

Level 2 (REPEAT): Failed to produce- documents verifying that the interpreting physician met the continuing experience-requirement of having interpreted or multi-read 960 mammograms in 24 months: Dr.[redacted] [see 21 CFR 900.12(a)(1)(ii)(A)].

We received your responses dated October 17 and November 6, 2006 to the MQSA Facility Inspection Report. Your responses were inadequate in that while you corrected the immediate deficiency, you have failed to implement corrective actions to prevent the recurrence of similar violations. Your facility has been cited for this violation, of the MQSA in your 2004, 2005, and 2006 annual inspections, Subsequent communication with our office on February 15 and April 3, 2007 failed to resolve this violation.

Because the continued failure to resolve this violation 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.tlte cost of on-site monitoring
• seeking civil money penalties up to T10,000 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 CFR 900.126(j).

FDA may need to perform a Compliance Follow 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 finding listed above and include:

the specific steps you have taken, or will take, to prevent the recurrence of similar violations, including projected timeframe for implementing those steps.

Please submit your response to this letter to:

Russell A. Campbell
Compliance Officer
U.S. Food and Drug Administration
1431 Harbor Bay Parkway
Alameda, CA 94502

Please send a copy of your response to:

Edward W. Gloor
Department of Health Services
Radiological Health Branch
P.O. Box 997414 MS 7610
Sacramento, CA 95899-7414

Finally, you should understand that there are many requirements pertaining to mammography. This letter pertains only to violations related to the recent inspection 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, NM 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 Russell A. Campbell at 510-337-6861.

Sincerely yours,

/S/

Barbara J. Cassens
District Director
U.S. Food and Drug Administration
San Francisco District

cc:
Edward W. Gloor
Department of Health Services
Radiological Health Branch'
P.O. Box 997414 MS 7610
Sacramento, CA 95899-7414

Priscilla F. Butler, M.S., FAAPM
Director; Breast Imaging Accreditation Programs,
American College of Radiology
1891 Preston White Drive
Reston, Virginia 22091