ML20023C913
| ML20023C913 | |
| Person / Time | |
|---|---|
| Issue date: | 09/19/1980 |
| From: | Fortuna R NRC OFFICE OF INSPECTOR & AUDITOR (OIA) |
| To: | Greenspun J JUSTICE, DEPT. OF |
| Shared Package | |
| ML20023A415 | List:
|
| References | |
| FOIA-82-515 NUDOCS 8305180285 | |
| Download: ML20023C913 (3) | |
Text
.,s SEP 19 1980 Fir. Julian Greenspun Deputy Chief for Litigation Criminal Division U.S. Departnent of Justice 1.'ashington, D.C. 20530
Dear Julian:
As I agread during our meeting on August 27, 1980, I am enclosing various copies of previously submitted documents which relate to our investigation of tiuclear Phannacy, Inc. (itPI).
I have, however, underlined (red) portions of the instant cubmission in an effort to highlight for you that available infomation/ evidence which serves to identify apparent willful and knowing violations of license conditions and regulations by liPI; which illustrates highly unprofessional and indeed unethical behavior on the part of tipi; and.which identifies possible consequences to the user of tipi'3 non-tiDA Xer.on.
In addition to documenting that flPI-liilwaukee distributed non-f4DA Xenon in willful violation of its license condition, the enclosed documents also indicate the following violations:
Recycling vials of unit dose quantities of Xenon in violation of a license condition and in a manner that could adversely impact upon the product's handlers and users. (liPI-!!ilwaukee, !1PI-Chicago, and tipi-Philadelphia)
Refilling preprinted !! Eft vials in contravention of the Food, Drug, and Cosmetic Act and in a manner that would result in a counterfeit and misbranded product. (riPI-Texas, fiPI-!!ilwaukee, and TIPI-Philadelphia)
~.
Withholding a copy of an tiRC byproduct license frorf a senior fiPI official (in violation of 19.11 of 10 CFR) in order to induce -the official to unwittingly perfonn certai.n financially profitable functions prohibited by the conditions in the license (fiPI-Chicago)
Receiving, acquiring, possessing, and transferring Xenon in the absence of a required license. (fiPI-Chicago)
Transferring nuclear material to an unlicensed recipient in violation of 30.41(b)(5) and 30.41(d) of 10 CFR. (fiPI-!iilwaukee) 8305180285 630412 PDR FOIA EMSHWIL82-515 PDR ll
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Mr. Julian Greenspun.
Regulgdypicking up nuclear waste material prior to receiving fiRC approva,1, knowing that such activity was in violation of 30.3 of 10 CFR. (flPI-Milwaukee)
,.s Fraudulently preparing documents showing that certain procedures
- had been carried out when, in fact, they had not been carried out.
(fiPI-Philadelphia)
Deceiving fiRC inspectors by switching employee film badges and causing false exposure records for. employees. (tipi-Chicago)
Instructing an official of the t1RC, who had concluded negotiations to cornence employment with fiPI at a future date, to maintain regular contact with unwitting employees of fiPI.
The fiRC official elicited infonnation from these unwitting employees relative to tipi's violations of flRC regulations and license conditions.
The fiRC official never -
made his f1RC superiors aware of these violations, nor did he let his superiors know that he was in regular and frequent contact with the staff of his future employer. The unwitting tipi employees thought that the referenced i4RC official was dealing with them in his official capacity'as a i epresentative and spokesman for the llRC.
(fiPI-Philadelphia)*
On the basis of the information available, it appears that, for purposes of profit, fiPI's misconduct was intentional and sufficiently serious and detrimental to constitute a defrauding of the United States in possible violation of 18 USC 371 and 1001, in that the Government was impaired and impeded in the performance of a lawful function, namely the administration of its byproduct regulating program, by the willful and knowing failure of liPI to adhere to conditions imposed upon it by various of its licenses and by the concealment of activities which it knew to be in violation of license conditions and re'gulations. _
Distribution:
Sincerely, Cripr.,Isipcd by 01A 01A Readin9 m;;r Fc:'.u.a RFortuna JStrickler Roger A. Fortuna, Assistaid Director
~
for Investigations Office of Inspector and Auditor
Enclosures:
As Stated
- On September 4,1980,
'(the liRC official referred to above) former I;RC supervl isors Ude"co~rdacted and they confirmed tha had been unaware that(" _ __
subsequent to his accepting employment with liPI, but v hile still in I:RC's employ, was dealing with I;PI employees iryge,dj (e supervisor stated that, had he known of such activity by{~ ~ _Iot,q,( 7 whi-1 v-sent4ng4d;=,el-r-es-anaf-fMal-of-theJPy'~~
he w d Tse"f ay6h iid66distFh'cti'6ii to'st'oy ~i t""""
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SEP 19 1980
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lir. Julian Greenspun Deputy Chief for Litigation Criminal Division U.S. Departr,cnt of Justice s
Ueshington, D.C. 20530
Dear Julian:
27, 1980, I am enclosing various As I agreed during our neeting on August copies of previously submitted documents which relate to our investigation of fluclear Phannacy, Inc. (NPI).
I have, however, underlined (red) portions of the instant sutraission in an effort to highlight for you that available infomation/ evidence which serves to identify apparent willful and knowing violations of license conditions and regulations by fiPI; which illustrates highly unpmfessional and indeed unethical behavior on the part of tipi; and which identifies possible consequences to the user of NPI's non-NDA Xenon.
In addition to documenting that !!PI-1111waukee distributed non-NDA Xenon in willful violation of its license condition, the enclosed dncunents also indicate the following violations:
Recycling vials of unit dose quantities of Xenon in violation of a license condition and in a manner that could adversely impact upon the product's handlers and users. (NPI-flilwaukee, NPI-Chicago, and I;PI-Philadelphia)
Eefilling preprinted flEN vials in contravention of the Food, Drug, and Cosmetic Act and ir, a manner that would result in a counterfeit and misbranded product. (NPI-Texas, HPI-flilwaukee, andI;PI-Philadelphia) k'ithholding a copy of an fiRC byproduct license from a senior NPI official (in violation of 19.11 of 10 CFR) in order'.to induce the official to unwittingly perfonn certain financially profitable functions prohibited by the conditions in the license (NPI-Chicago)
Receiving, acquiring, possessing, and transferring Xenon in the absence of a required license. (NPI-Chicago) nuclear material to an unlicensed recipient in violation Transferrin of 30.41(b) 5) and 30.41(d) of 10 CFR. (NPI-flilwaukee) d' f}L,
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