ML19350A266
| ML19350A266 | |
| Person / Time | |
|---|---|
| Issue date: | 03/09/1981 |
| From: | Stello V NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | Hebner M PHARMATOPES, INC. |
| References | |
| EA-81-016, EA-81-16, NUDOCS 8103130357 | |
| Download: ML19350A266 (2) | |
Text
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UNITED STATES
[g' T y.,( h NUCLEAR REGULATORY COMMISSION 5 h* M j ^ !
E WASHINGTON, D. C. 20555 o
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License No. 21-17189-01MD 4
EA 81-16 e
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ATTN:
Mark T. Hebner
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25721 Coolidge Highway 4
Oak Park, MI 48237 b
Gentlemen:
This refers to the investigation conducted by Messrs. J. B. McCarten and D. G.
Wiedeman of our staff on September 24-26 and October 2-3, 1980, of activities at the Detroit Central Hospital, Detroit, Michigan and at Pharmatopes, Incorporated, authorized by NRC Byproduct License No. 21-17189-01MD.
The' results of this investigation were discussed between Mr. Mark T. Hebner, President, Pharmatopes, Incorporated, and Messrs. James B. McCarten and Darrel Wiedeman of the NRC Region III office on October 3, 1980.
In addition, the results were also discussed during an enforcement conference in the Region III office on January 26, 1981, between you and Mr. A. B. Davis, Deputy Director, Region III and others of the staff.
Specifically, the investigation centered on the loss of a radiopharmaceutical from a Pharmatopes, Incorporated delivery vehicle in the vicinity of Detroit Central Hospital, Detroit, Michigan.
The loss resulted in the radioactive contamination of public property and of a member of the public.
As you know, the NRC has taken steps to increase the standard of compliance in the area of transportation of. radioactive materials.
A December 3, 1979, letter which was sent to all NRC licensees, set forth the criteria for categorizing violations in this area.
In view of the severity of two of the items of noncompliance, we propose to impose civil penalties in the amount of One Thousand Five Hundred Dollars for the alleged items of noncompliance set forth in Appendix A.
Appendix B to this letter is the Notice of Proposed Imposition of Civil Penalties.
You are required to respond to the Notice of Violation, and in preparing the response, you.should follow the instructions set forth in Appendices A and B.
Additional items of noncompliance in the areas of health physics were also identified during the course of this investigation, which are set forth in Appendix A.
While no civil penalties are assessed for these additional items, we are concerned that the control of licensed activities were not sufficient to preclude their occurrence.
Of particular concern is the f ailure to perform bioassay procedures to determine the internal exposure of. individuals handling significant quantities of iodine-131 and technetium-99m.
Moreover, your firm CERTIFIED MAIL RETURN RECEIPT REQUESTED 81081303
EAR 0 ; coi Pharmatopes, Incorporated was recently the subject of a civil penalty action (EA 81-03) for health physics violations at your Washington, D.C. facility.
Therefore, in addition to your response to the specific items of noncompliance, please describe your plans to improve your controls of licensed activities to assure greater adherence to regulatory requirements.
Your response to the enclosed Notice of Violation, along with our findings from our continuing inspection program, will be considered in determining whether any further enforcement actions such as modification, suspension or revocation of your license is appropriate.
In accordance with Section 2.790 of the NRC's " Rules of Practice," Part 2, Title 10, Code of Federal Regulations, a copy of this letter and the enclo-sure will be placed in the NRC's Public Document Room.
Sincerely, Victor Stello, J'r.
Director Office of Inspection and Enforcement
Enclosures:
f 1.
Appendix A, Notice of Violation 2.
Appendix B, Notice of Proposed Imposition of Civil Penalties i
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