ML20041B920
| ML20041B920 | |
| Person / Time | |
|---|---|
| Issue date: | 02/10/1982 |
| From: | Deyoung R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | Hebner M PHARMATOPES, INC. |
| References | |
| EA-82-016, EA-82-16, NUDOCS 8202250380 | |
| Download: ML20041B920 (2) | |
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/l E eL A FEB 10 W IE HQ FILE CO?T 1
License No. 34-16654-01MD
' ' M// d EA 82-16 i
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Pharmatopes, Incorporated i
ATTN: Mr. Mark Hebner id2a
'iO President E
'i" 10646 North End 1
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Ferndale, Michigan 48220 t
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Gentlemen:
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On November 3 and 4,1981, Mr. S. R. Lasuk of our Region III (Chicago) office inspected activities at your facility in Toledo, Ohio, which is authorized to operate under NRC Byproduct Material License No. 34-1664-01MD.
During an enforcement conference on November 18, 1981, in the Region III office the results of the inspection involving an extremity exposure were discussed with Messrs. Monty M. C. Fu and Robert F. Irwin of Pharmatopes, and Mr. A. B. Davis and others of the Region III staff.
As you are aware, three civil penalties have been imposed on Pharmatopes, Incorporated, since December 1980, two of which also involved extremity i
exposures. One of these extremity exposures occurred at your Washington, DC facility under the same Radiation Safety Officer who is now the Radiation Safety Officer at your Toledo, Ohio facility where the most recent extremity exposure occurred. We are concerned about the recurrence of these violations and believe they indicate a breakdown in your health physics controls in an area which should be of particular concern to a nuclear pharmacy, i.e.,
extremity exposures.
We have not yet determined whether additional civil penalties should be proposed or whether more stringent actions such as license suspension would be appropriate.
Your corrective actions taken in response to previous civil penalty actions have addressed the problem of overexposures at a specific facility. However, i
the recurrence of the same problem at your other licensed facilities indicates that a more generic approach to corrective action is needed.
Therefore, we would like to meet with you within 30 days to discuss what actions l
you have taken or will take to improve your health physics program at all of your NRC-licensed facilities, with particular attention to the development and implementation of procedures to prevent extremity overexposures.
i CERTIFIED MAIL RETURN RECEIPT REQUESTED t
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8202250380 820210 NMS LIC30 34-16654-01MD PDR.
e Pharmatopes, Incorporated Please contact Mr. James Lieberman (301-492-4909), Director of Enforcement, to make arrangements for the meeting at my office in NRC Inspection and Enforcement Headquarters, 4350 East-West Highway, Bethesda, flaryland.
Sincerely,
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E. C.1,su az n Richard C. DeYoung, Director Office of Inspection and Enforcement Distribution PDR RCDeYoung, IE JHSniezek, IE JLieberman, IE LCobb, IE FIngram, PA JMurray, ELD (3)
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