ML20206C960
| ML20206C960 | |
| Person / Time | |
|---|---|
| Issue date: | 11/02/1988 |
| From: | Russell W NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20206C956 | List: |
| References | |
| 30-18966-88-01, 30-18966-88-1, EA-88-269, NUDOCS 8811160483 | |
| Download: ML20206C960 (1) | |
Text
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NOTICE OF VIOLATION Syncor Corporation Docket No. 030-18966 Fairfield, New Jersey License No. 29-19608-01MO EA 88-269 During an NRC inspection conducted on August 11-12 and October 5, 1988, a violation of NRC requirements was identified.
In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," 10 CFR Part 2, Appendix C (1988), the violation is set forth below:
Condition 23 of License No. 29-19608-01MD requires that licensed material be
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possessed and used in accordance with statements, reprtsentations and procedures in an application dated April 25, 1986 and certain specific letters.
Item 10.13 of this application describes the required customer container labeling, which includes specification of the name of the radiopharmaceutical.
Contrary to the above, between September 21, 1987 and March 25, 1988, syringes, vial shields and/or ur.it dose container shields containing radioactive material were labeled with the wrong radiopharmaceutical name l
on four separate occasions, which resulted in four misadministrations by 1
l hospitals.
This is a Sevarity Level III violation (Supplement VI).
Pursuant to the provisions of 10 CFR 2.201, Syncor Corporation (Licensee) is hereby required to submit a written statement or explanation to the U.S.
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Nuclear Regulatory Commission, ATTN: Document Control Oesk, Washington, D.C.
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20555 with a copy to the Regional Administrator, Region I, within 30 days of f
the date of the letter transmitting this Notice.
This reply should be clearly a
marked as a "Reply to a Notice of Violation" and should include for each l
violation: (1) the reason for the violation if admitted, (2) the corrective
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steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date when full l
compliance will be achieved.
If an adequate reply is not received within the time specified in this Notice, an order may be issued to show cause why the license should not be modified, suspended, or revoked or why such other action l
as may be proper should not be taken.
Consideration may be given to extending I
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the response time for good cause shown.
FOR THE NUCLEAR REGULATORY COMMISSION I
Originni Signed By KILLI/.J T. LUSSl L William T. Russell Regional Administrator DatedatKJngofPrussia, Pennsylvania this J day of hovember 1988.
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29-19600-01 MD PNV