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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Women's Diagnostic Center 11-Jun-02

Department of Health and Human ServicesDepartment of Health and Human Services            Public Health Service


Central Region
Food and Drug Administration
Waterview Corporate Center
Telephone (973) 526-6007
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
Telephone: (973) 526-6007

June 11, 2002

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Barry I. Franklin, MD
Radiologist
Women's Diagnostic Center
89 Sparta Avenue, Suite 120
Sparta, New Jersey 07871

FILE NO.: 02-NWJ-23
Inspection ID NO.: 1477100007

Dear Dr. Franklin:

A representative from the State of New Jersey under contract to the Food and Drug Administration (FDA) inspected your facility on May 20, 2002. This inspection revealed a serious regulatory problem involving mammography performed at your facility.

Under a United States Federal law, the Mammography Quality Standards Act of.1992 (MQSA) 42 U.S.C, 263b, 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 violation(s) of Section 354(f) of the Act [42 U.S.C. 263b(f)) at your facility (identified on your inspection report):

  • Your facility failed to document that phantom image quality control testing was performed. [See 21 CER 900.12(e)(2)]. . Phantom image quality control records were missing for the following weeks:
  • October 15-20, 2001
  • November 5-10, 2001
  • December 3-8, 2001
  • January 21-26, 2002

Your facility failed to document that processor quality control testing was performed. [See 21 CPR 900.12(e)(1)]

Processor quality control records were missing for the following days:

  • August 17, 2001
  • August 20-23, 2001
  • September 7, 2001
  • October 17, 2001
  • November 2, 2001
  • November 29, 2001
  • December 7, 2002
  • January 26, 2002
  • April 4, 2002

The specific problems noted above appeared on your MQSA Facility Inspection Report, which was issued to your facility at the close of the inspection.

Because these conditions may be symptomatic of serious underlying problems, they could compromise the quality of mammography at your facility. They represent serious violations 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, the Standards, suspension or revocation of your facility's FDA certificate, or obtaining a court injunction against further mammography (see Sections 354(h) through (j) of the Act, 42 U.S.C. 263b(h) through (j)).

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 you received this letter:

  • the specific steps you have taken to correct 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 record keeping procedures.

Please submit your response to Rosa L. Brown, Compliance Technician, Food and Drug Administration, New Jersey District, 10 Waterview Blvd, 3rd Floor, Parsippany, New Jersey 07054.

Finally, you should understand that there are many FDA requirements pertaining to mammography. This letter pertains only to findings disclosed during the 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.

If you have technical questions about mammography facility requirements, or about the content of this letter, please feel free to contact Elizabeth A. Laudig at (410) 779-5441.

Sincerely,

/s/

Douglas I. Ellsworth

District Director.

New Jersey District Office