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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Good Samaritan Health Systems 22-Oct-02

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


Food and Drug Administration

Kansas City District

Southwest Region

11630 West 80th Street

Lenexa, Kansas 66214-3340

Telephone: (913) 752-2100

October 22, 2002

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

WARNING LETTER

Ref. KAN 2003-02

Mr. Kenneth Tomlon

President & Chief Executive Officer

Good Samaritan Health Systems

10 East 31st Street

Kearney, NE 68847

Dear Mr. Tomlon:

During an inspection of your blood bank operation located at the above address on August 29-30, 2002, an investigator from this office documented violations of Section 501(a)(2)B) of the Federal Food, Drug; and Cosmetic Act and Title 21, Code of Federal Regulations (21 CFR), Parts 600-680 as follows:

Failure to investigate adverse reactions and maintain appropriate records. [21 CFR 606.170(a)] Specifically, of approximately thirty-eight transfusion reactions documented during 2002, only five have been investigated.

The above identified deviation is not intended to be an all inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment is in compliance with all requirements of the federal regulations,

You should take prompt measures to correct this deviation. Failure to promptly correct this deviation may result in regulatory action without further notice. Such action includes seizure and/or injunction.

Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violation and to prevent recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your reply should be sent to Nadine Nanko Johnson, Compliance Officer, at the above address.

Sincerely

/s/

Charles W. Sedgwick

District Director

Kansas City District