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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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The Women's Place 11-Jul-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

 

New York District
Food & Drug Administration
300 Pearl Street, Suite 100
Buffalo, NY 14202

July 11, 2001
WARNING LETTER NYK 2001-94
CERTIFIED MAIL
RETURN RECEIPT REQUESTED

RE: Facility ID Number 221025

Susan Merola-McConn, Executive Director
North Medical P.C. d.b.a. The Women?s Place
4117 Medical Center Drive
Fayetteville, New York 13066

Dear Ms. Merola-McConn:

Your facility was inspected on June 27, 2001 by a representative of the New York State Department of Health, acting on behalf of the Food and Drug Administration (FDA). This inspection revealed serious regulatory problems involving the mammography at your facility.

Under a United States Federal law, the Mammography Quality Standards Act of 1992, your facility must meet specific requirements for mammography. These requirements help protect the health of women by assuring that a facility can perform quality mammography. The inspection revealed the following Level 1 finding at your facility:

  • Phantom QC records were missing for at least four (4) weeks for the mammography unit 1.

The specific problem noted above appeared on your MQSA Facility Inspection Report which was issued to your facility at the close of the inspection. This problem is identified as a Level 1 because it identifies a failure to meet a significant MQSA requirement.

Because this condition may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, it represents a violation of the law which may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, placing your facility under a Directed Plan of Correction, charging your facility for the cost of on-site monitoring, assessing 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, suspension or revocation of your facility?s FDA certificate, or obtaining a court injunction against further mammography.

It is necessary for you to act on this matter immediately. Please explain to this office in writing within fifteen (15) working days from the date that you receive this letter, each step your facility is taking to correct this violation and to prevent the recurrence of similar violations.

In addition, your response should address the Level 2 finding that was listed on the inspection report provided at the close of the inspection. The Level 2 finding is:

  • Failure to produce documents verifying that the interpreting physician, [redacted] met the initial experience requirement of having interpreted or multi-read 240 mammograms in a six(6) month period.

Please submit your response to the above issues to the attention of Lisa M.Utz, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, NY 14202, telephone (716) 551-4461 ext.3117.

Finally, you should understand 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, Maryland 21045-6057 (1-800-838-7715), or through the Internet at http://www.fda.gov.

Sincerely,

/s/

Timothy E. Hansen

Acting District Director