ML20033D343
| ML20033D343 | |
| Person / Time | |
|---|---|
| Issue date: | 10/19/1981 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | |
| Shared Package | |
| ML20033D333 | List: |
| References | |
| NUDOCS 8112070550 | |
| Download: ML20033D343 (1) | |
Text
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.,,h, APPENDIX A NOTICE OF VIOLATION I
Food and Drug Administration License No. 01-157701-01 As a result of the inspection conducted on September 30, 1981, and in accordance
, with the Interim Enforcement Policy, 45 FR 66754 (October /,1980), the following violation was identified.
License Condition 30.3 requires that licensed material be possessed and used in accordance with the terms and conditions of your license.
License Conditions 6G, 7G, and 9G state that the only authorized use of nickel-63 is for storage only in a Tracor Model 111019 ' detector cell.
Contrary to the above, the requirement to possess and use licensed material under the conditions of your license was not met in that a nickel-63 foil in a Tracor Model 111019 detector cell was in actual use from September 1979 t'o April 1981 and a nickel-63 foil in a Perkin Elmer Model 3920 gas chromato-graph was received by you in August 1981.
This is a Severity Level V Violation (Supplement VII).
Pursuant to tae provisions of 10 CFR 2.201, you are hereby required to submit to
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this office within *.hirty days of the date of this Notice,' a written 5 atement or explanation in reply, including: (1) admission or denial of the ' alleged viola-tions; (2) the reasons for the violations if admitted; (3) the corrective steps-which have been'taken and the'results achieved; (4) corrective steps which will be taken to avoid further violations; and'(5) the date when full compliance will be achieved. Consideration may be given to extending'your response time for good cause shown. Under the authority of Section 182. of the Atomic Energy Act of 1954, as amended, this response shall be submitted under' oath or affirmation.
The responses directed by this Notice are not subject to the clearance procedures of the Office of Management'and Budget as required by the Paperwork Reduction Act-of 1980, PL'96-511.
. Date: OCT 19 E
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