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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Mary Immaculate Hospital 19-Oct-01

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Baltimore District Office

900 Madison Avenue

Baltimore, MD 21205-2199

Telephone: (410) 962-3396

CFN:1124094

Facility ID:122317

Inspection ID#1223170007

02-BLT-01

October 19, 200l

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Muhammad Ali Siddiky, M.D.

Mary Immaculate Hospital

2 Bernadine Drive

Newport News, Virginia 23602

Dear Dr. Siddiky:

A representative from the Commonwealth of Virginia under contract to the Food and Drug Administration (FDA) inspected your facility on September 27, 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:

Your facility failed to produce documents verifying that radiologic technologis [redacted] met the initial requirement of holding either a valid state license or a valid certificate from and FDA approved body.

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 Level 1 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; suspension or revocation of 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:

Your facility failed to produce documents verifying that the radiologic technologist [redacted] met the alternative initial requirement of having training specific to mammography under the interim regulations.

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 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.

Your response should be submitted to: Food and Drug Administration, 900 Madison Avenue, Baltimore, Maryland 21201, to the attention of Anita Richardson, Director, Compliance Branch.

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 may 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) 962-3591, extension 159.

Sincerely,

Lee Bowers

Director, Baltimore District