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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Saint James Hospital 11-Dec-01


Public Health Service

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

December 11, 2001
FILE NO.: 02-NWJ-14
Inspection ID NO.: 1386510007

Mr. Robert DelGuidice
Vice-president operations
Saint James Hospital
Diagnostic Radiology
155 Jefferson Street
Newark, New Jersey 07105

Dear Dr. DelGuidice:

A representative from the State of New Jersey under contract to the Food and Drug Administration (FDA) inspected your facility on November 16, 2001. This inspection revealed a serious regulatory problem involving mammography performed at your facility.

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

Processor Quality Control (QC) records for Processor #l [redacted] which document the performance of processor quality control testing, were missing for at least 5 consecutive days during the month of March 2001.

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 One finding because it identifies a failure to comply with a significant MQSA requirement.

Because this condition may be symptomatic of serious underlying problems that could compromise the quality of mammography performed at your facility, it represents a violation of the law that 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; suspending or revoking your facility?s FDA certificate; or obtaining a court injunction against further mammography.

In addition, the following Level 2 finding was listed on the inspection report provided to you at the close of the inspection:

Processor QC records were missing for at least 10%, but less than 30%, of processor operating days.

You must act on this matter immediately. Please explain or provide to this office in writing within 15 working days from the date that you receive 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, if the findings relate to quality control or other records.

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. Thins 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.

District Director
New Jersey District Office