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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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FDA Response to Warning Letter

   

Department of Health and Human Services' logoDepartment of Health and Human Services

 Public Health Service
Food and Drug Administration
  Cincinnati District office
Central Region
6751 Sager Drke
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2772



October 25, 2002
RE: Inspection ID - 1236950009

Mr. Gary D. Hallman
President and Chief Executive Offker
Medina General Hospital
1000 East Washington St.
Medina, OH 44256-2170

Dear Mr. Hallman:

Your mammography operation was inspected on August 15, 2002 by a representative from the Ohio Department of Health radiation control program under contract to the Food and Drug Administration or (of the Food and Drug Administration). This inspection revealed that your facility failed to comply with the Quality Standards for Mammography (Standards) as specified in 42 U.S.C. 263b(f) and Title 21, Code of Federal Regulations (CFR), Section 900.12.

On October 8, 2002, you responded to the Waming Letter, dated September 17, 2002. Based on your response, your facility has now met the annual MQSA inspection requirement. The corrective action you have implemented will be evaluated during your next inspection.

Your response documents will be made a permanent part of our inspection file.

Sincerely yours,
/s/

R. Terry Bolen
MQSA Compliance Officer
Cincinnati District Office

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