ML20011A238
| ML20011A238 | |
| Person / Time | |
|---|---|
| Issue date: | 10/02/1981 |
| From: | Sreniawski D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20011A235 | List: |
| References | |
| NUDOCS 8110080353 | |
| Download: ML20011A238 (1) | |
Text
'
itt.,
'o' Appendix A a
NOTICE OF VIOLATION gy UnioiUfospital-License No. 13-16457-01 3
As~a-result of the inspection conducted on September 16, 1981, and in
'accordance with' the-Interim Enforcement Policy,' 45 FR 66754 (October 7,
~
- 1980), the'following violation was identified:
10 CFR 35.14(b)(6) require:; LL.,t for Groups I, II and III any licensee using byproduct material for clinical procedures other than those specified in the' product labeling (package insert) shall comply with the labeling regarding:
(i)
Chemical and physical form;
- (ii)
Route of administration; and,
.(iii)
' Dosage range.
C
-Contrary to this requirement, it was determined through statements by licensee representatives that during the last three months, two intra-catheterizations of.the urinary bladder (Cystograms) were performed.
This procedure is not described in the manufacturer's package insert
'as an authorized rout;e of administration.
This is a Severity Level V violation (Supplement VII).
Pursuant to the provisions of 10 CFR 2.201, you are required to submit to this office within thirty days of the date of this Notice a written statement or explanation in reply, including for each item of noncompliance:
(1) cor-rective action taken and the results achieved; (2) corrective action to be taken to avoid further noncompliance; and (3) the date when full compliance will be achieved. Under the authority of Section 182 of the Atomic Energy Act of 1954, as amended, this response shall be submitted under oath or affirmation. Consideration may be given to extending your response time
'for good cause shown.
/.
Dated /0 2 M
('p) Materials Radiation Protection
[
D. J. Sreniawski, Chief y
Section 2 L
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