ML20031H404
| ML20031H404 | |
| Person / Time | |
|---|---|
| Issue date: | 10/09/1981 |
| From: | Wiedeman D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20031H398 | List: |
| References | |
| NUDOCS 8110270450 | |
| Download: ML20031H404 (1) | |
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Appendix A NOTICE OF VIOLATION Smith Kline Clinical License No. 24-13299-01 Laboratories, Inc.
As a result of the inspection conducted on Septcmber 10, 1981, and in ac-cordance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980),
the following violations were identified:
1.
License Condition No. 14A and B states tha; each chromatograph detector containing nickel-63 shall be tested for leakage and/or contamination at intervals not to exceed six months. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the Commission.
Contrary to this requirement, the last recorded leak test result for the F and M Model 2-6195 detector cell and the Hewlett-rackard Model 18713A detector cell was on May 22, 1980.
This is a Severity Level VI violation (Supplement VII).
2.
License Condition No. 23 states that a physical inventory shall be con-ducted every six months to account for all sealed sources receive ? and possessed.
Records of the inventories shall be mttntained for two years from the date of the inventory and shall include the quantities and kinds of byproduct material, location of sealed sources, and the date of the inventory.
Contrary to this requirement, records of the inventories of sealed sources were not maintained for 1980 and 1981.
This is a Severity Level VI 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 ex-olanation in reply, including for each item of noncompliance:
(1) corrective action taken and the results achieved; (2) corrective action to be taken to avoid further noncompliance; and (3) the date when full compliance witl 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. Con-sideration may be given to extending your response time for good cause shown.
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e Dated D. G. Wiede fting Chief Materials iation Protection Section 1 8110270450 811015 NMS LIC30 24-13299.;1 PDR