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Department of Health and Human Services
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-12-03
October 20, 2011
Re: MQSA Inspection ID #1944150016
FEI #1000525817
Alberto Eiber, M.D.
President
Eiber Radiology, Inc.
President
Eiber Radiology, Inc.
49 West 49th Street
Hialeah, FL 33012
Dear Dr. Eiber:
On July 19, 2011, a representative of the United States 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 MQSA violations observed during the current inspection were noted on the MQSA Facility Inspection Report and the document "Important Information about Your MQSA Inspection" that the inspector mailed to your facility on August 5, 2011. These violations (referenced below as deviations from the quality standards set forth in Title 21 Code Of Federal Regulations Part 900 Section 12 [21 CFR 900.12]) are identified below.
Level 2: Failed to produce documents verifying that you, the interpreting physician, met the continuing education requirement of having taught or completed at least fifteen (15) category 1 continuing medical education units in mammography in thirty-six (36) months. [See 21 CFR 900.12(a)(1)(ii)(B) & (a)(4).]
Level 2: Failed to produce documents verifying that you, the interpreting physician, met the continuing experience requirement of having interpreted or multi-read nine hundred sixty (960) mammograms in twenty-four (24) months. In 2009, you read ninety (90) mammograms. In 2010, you read thirty-eight (38) mammograms. From January to April 2011, you read two hundred twenty-two (222) mammograms. [See 21 CFR 900.12(a)(1)(ii)(A) & (a)(4).]
On February 9, 2011, you signed SECTION G of an American College of Radiology (ACR) form entitled "PERSONNEL · RADIOLOGIST (INTERPRETING PHYSICIAN)." For question #7 on the form, which reads, "How many mammographic examinations have you personally interpreted over the previous 24-month period? (include mammograms interpreted for this and other facilities, if you review for multiple sites)," the number “1,200” was written. No documentation was provided during the inspection to support that you had interpreted or multi-read this number of mammograms in the twenty-four (24) months prior to this date or that you had met the continuing experience requirement at the time of the inspection.
Because the continued failure to resolve these violations 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
See 42 USC 263b(h)-(j) and 21 CFR 900.12(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 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.
Please submit your response to this letter to:
FDA – Florida District Office
Attn: Matthew B. Thomaston
555 Winderley Place
Suite 200
Maitland, FL 32751
Please send a copy of your response to:
State of Florida
Radiation Control Office
705 Wells Road
Suite 300
Orange Park, FL 33609
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, 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 contact Michael P. Divine, M.S., at 301-796-5913.
Sincerely,
/S/
Emma R. Singleton
Director, Florida District
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