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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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Pinehurst Women's Clinic, P.A. 22-Jun-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

 

June 22, 2001


VIA FEDERAL EXPRESS

Joel Puleo, M.D.
Pinehurst Women’s Clinic, P.A.
8 Memorial Drive
Pinehurst, NC 28374-8707

Inspection ID: 1944800007

WARNING LETTER
(01-ATL-49)

Dear Dr. Puleo:

Your facility was inspected on 5/31/01 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 certain Quality Standards for Mammography as specified in Title 21, Code of Federal Regulations (CFR) , Part 900.12, as follows:

Repeat Level 2 Non-Compliance

1. The time period between the previous and current surveys for x-ray unit #1 [redacted] exceeds 14 months.

Level 2 Non-Compliance

2. The phantom image score (using an FDA-approved mammography phantom) is at least 3 fibers but is less than 4 fibers for unit #1, [redacted] located in the mammography room.

3. Failure to produce documents verifying that the radiologic technologist, [redacted] met the continuing education requirement of having taught or completed at least 15 continuing education units in mammography in 36 months.

The specific deficiencies noted above appeared on your MQSA Facility Inspection Report which was issued to your facility following the close of the inspection. Item #1 was also cited in the previous inspection of your facility.

Because the above deficiencies may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, they represent serious violation of the law which may result in FDA taking regulatory action without further notice to you. If you fail to promptly correct these deficiencies, FDA may, without further notice, initiate regulatory action. Under MQSA, FDA may:
  • impose civil money penalties on a facility of up to $10,000 for each failure to substantially comply with, or each day of failure to substantially comply with, the Standards.
  • suspend or revoke a facility’s FDA certificate for failure to comply with the Standards.
  • seek an injunction in federal court to prohibit any mammography activity that constitutes a serious risk to human health.

It is your responsibility to ensure adherence to each requirement of the Mammography Quality Standards Act of 1992 (MQSA) and FDA’s regulations. You are responsible for investigating and determining the causes of the deficiencies that the inspection identifies and promptly initiating permanent corrective actions.

Please note that FDA regulations do not preclude a State from enforcing its own State mammography laws and regulations. In some cases, these requirements may be more stringent than FDA’s. When you plan your corrective action(s), therefore, you should consider the more stringent State requirements, if any.

Within 15 working days after receiving this letter, you should notify FDA in writing of:

  • 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 noncompliances that were found relate to
    quality control or other records. (Note: Patient names or
    identification should be deleted from any copies submitted.)
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


With a copy to:

North Carolina DENR
Division of Radiation
3825 Barrett Drive
Protection
Raleigh, NC 27609-7221

and


Thomas Clarida
U.S. Food and Drug Administration
5701 Executive Center Drive, Suite 104
Charlotte, NC 28212


(NOTE : If phantom image is required for corrective action, please submit original to North Carolina DENR, Division of Radiation Protection. )

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

You may choose to address both FDA and state requirements in your response. 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,

Ballard H. Graham, Director
Atlanta District

Cc: Ms. Priscilla F. Butler, M.S., FAAPM, FACR
Director
Breast Imaging Accreditation Programs
1891 Preston White Drive
Reston, Virginia 20191

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