ML20010E148
| ML20010E148 | |
| Person / Time | |
|---|---|
| Issue date: | 08/25/1981 |
| From: | Norelius C NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | David Nelson RIVERVIEW HOSP. WISCONSIN RAPIDS, WI |
| Shared Package | |
| ML20010E149 | List: |
| References | |
| NUDOCS 8109030145 | |
| Download: ML20010E148 (1) | |
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Riverview Ilospital License No. 48-12878-01 ATTN:
Mr. Dean W. Nelson 410 Dewey Street Wisconsin Rapids, WI 54494 Gentlemen:
Thank you for your letter dated August 3, 1981, informing us of the steps have taken to correct the noncompliance which we brought to your attention in our letter dated June 16, 1981. We will examine these matters during a future inspection.
Regarding your statement that you do not feel the item of noncompliance was valid or reasonable, during a recent telephone conversation with William J. Gyarfas, M.D.,
Director, Division of Oncology and Radio-pharmaceutical Drug Products, Food and Drug Administration, Dr. Gyarfas stated that the efficacy of the route of administration for nuclear cystograms has not been demonstrated to the Food and Drug Administration; therefore, an IND would be required for cystograms using radiopharmaceuticals.
On this basis, we viewed this matter as an item of noncompliance.
Your cooperation with us is appreciated.
Sincerely, C. E. Norelius, Director Division of Engineering and Technical Inspection cc w/1tr dtd 8/3/81:
Andrew ?!. Lucas, M.D.
DMB/ Document Control Desk (RIDS)
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