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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Physicians East-Greenville Obstetrics and Gynecology 10-Jun-02

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

Public Health Service
Food and Drug Administration

 

Atlanta District Office
50 Eighth Street N.E.
Atlanta, Georgia 30309


June 10, 2002

VIA FEDERAL EXPRESS

Florence G. Blackman, M.D.
Physicians East-Greenville Obstetrics and Gynecology
101 Bethesda Drive
Greenville, NC 27834

Inspection ID: 1148430009

WARNING LETTER
(02-ATL-29)

Dear Dr. Blackman:

Your facility was inspected on 4/30/02 by a representative of the North Carolina Department of Environment & Natural Resources (DENR), Division of Radiation Protection, acting on behalf of the Food and Drug Administration (FDA). This inspection revealed that your facility failed to comply with the Mammography Quality Standards Act of 1992 (MQSA) and certain Quality Standards for Mammography as specified in Title 21, Code of Federal Regulations (CFR), Part 900.12, as follows:

1. Your facility failed to produce documents verifying that the interpreting physician, [redacted] met the initial experience requirement of having interpreted or multi-read 240 mammograms in 6 months. (21 CFR 900.12 (a)(i)(i)(D)]

2. Your facility failed to produce documents verifying that the radioiogic technologist, [redacted] met the continuing education requirement of having taught or completed at least 15 continuing education units in mammography in 36 months. [(900.12 (a)(2)(iii)]

The specific problems noted above appeared on your MQSA Facility Inspection Report, which was issued to your facility at the close of the inspection. These problems are identified as Level 2, because they identify a failure to meet significant MQSA requirements as described above. The first deficiency listed above is a repeat finding from the previous Inspection of your facility on 6/6/01.

Because these conditions may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, they represent a serious violation of the law which may result in FDA imposing statutory sanctions without further notice to you. These actions include, but are not limited to, placing your facility under a Directed Plan of Correction (DPC) and/or charging your facility for the cost of on-site monitoring.

Failure to correct these violations promptly could, also cause FDA to seek 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 or to seek suspension or revocation of your facility's FDA certificate.

It is necessary for you to act on this matter immediately. Please explain to this office, in writing, within fifteen (15) working days after receiving this letter.

• the specific steps you have taken to correct all of the violations noted in this letter,
• each step your facility is taking to prevent the recurrence of similar violations;
• equipment settings (including technique factors), raw test data, and calculated final results, where appropriate; and
• sample records that demonstrate proper recordkeeping procedures, if the noncompliance that were found relate to quality control or other records. (Note: Patient names or identification should be deleted from any copies submitted.)

The other items listed on your 4/30/02 facility inspection report identified as Level 3 Noncompliance should also be corrected.

If your facility is unable to complete the corrective action within 15 working days, you should state the reason for the delay and the time within which corrections will be completed. Please send the original copy of your response to: Serene - A. Kimel, Compliance Officer. U.S. Food and Drug Administration, 60 8th St., NE, Atlanta, GA 30309. You should also send a copy to the North Carolina DENR, Division of Radiation Protection, 3825 Barrett Drive, Raleigh, NC 27609-7221 and to Thomas Clarida U.S. Food and Drug Administration, 5701 Executive Center Drive, Suite 104, Charlotte, NC 28212.

Finally, you should understand that there are many FDA requirements pertaining to mammography. This letter pertains only to findings of your inspection 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 any questions regarding this letter or how to ensure you are meeting MQSA standards, please call Thomas Clarida at 704-344-6116.

Sincerely yours,

/S/

Ballard H. Graham, Director
Atlanta District