ML20040B920

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Forwards Documents Re Investigation of Nuclear Pharmacy,Inc, Consisting of Statements,Repts of Interview & Memorandums. Portions Deleted.W/O Encl
ML20040B920
Person / Time
Issue date: 04/16/1980
From: Fortuna R
NRC OFFICE OF INSPECTOR & AUDITOR (OIA)
To: Greenspan J
JUSTICE, DEPT. OF
Shared Package
ML20040B919 List:
References
FOIA-81-349 NUDOCS 8201260592
Download: ML20040B920 (21)
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Text

{{#Wiki_filter:_ [.v ' * % 'c UNil LD s1 ATLs NUCLEAR REGULATORY COMMISSION E '* .J/ i WASHINGTON, D. C. 20555 2 kb,.,/ 'e.YrM!Lg} % w. - APR 161980 Mr. Julian Greenspun Deputy Chief for Litigation Criminal Division U.S. Department of Justice Washington, D.C. 20530

Dear Julian:

The purpose of this letter is to provide you with a number of documents not previously furnished to you, which we obtained through our investigation of Nuclear Phannacy Inc. (NPI). They consist of statements, reports of interview, merr.orandums, etc. To facilitate your review, each of the documents are identified below and following the description of each document, is a brief summary of its content. As you can appreciate, the. summaries are narrow and should not be considered all encompassing as far as their total relevan,ce is concerned. DOCUMENT 1 February 12, 1980 statement o - Chief Technician, Nuclear Medicine Department, ues asp a, Milwaukee, Wisconsin. M states that it was her assumption that when F'I delivered unit doses of Xenon-133 in NEN vials, the product was, in fact NENs. She had no knowledge that the Xenon-133 received from HPI was of commercial, rather than phannaceutical, quality. NPI knew that St. Luke's ordered Xenon-133 for diagnostic work in humans and St. Luke's relied on NPI to furnish a product suitable for human use. NPI's label which stated, in ~part, that "...This radiophannaceutical is licensed by the U.S. Nuclear Regulatory Commission..." served as partial assurance to St.. Luke's that it was receiving a product which met all of the requisites for human use. Bd01ff"S2o9ao --- d 82 ~ m.m>....... s - +................. 1-ao o m >...................................i........ .:....:................. 1

~ Mr. Julian Greenspun - DOCUMENT 2 February 13, 1980, statement of D6*MWw ws1 Director, Department of Nuclear Medicine, St. Luke's Hosp!tal m awaukee, wisconsin. wu ~4,4M states that St. Luke's purchased Xenon-133 from NPI for use as a radiopharmaceutical to diagnose lung conditions in humans. It was purchased by St. Luke's pursuant to a license from the NRC. The Xenon-133 received from NPI was never labeled in a manner indicating it was not for human use. NPI knew that St. Luke's used the Xenon-133 as a diagnostic drug and St. Luke's relied upon NPI to furnish a suitable product. DOCUMENT 3 March 18,1980 statement of OS'kdLM Registered Pharmacist. Mr.ki;pr states that in/about late August 1979 he was visiting at St. Luke's Hospital in Milwaukee and toured the nuclear medicine area. He viewed, stocks of unit dose vials of Xenon-133 and all appeared to have NEN labeling. After examining NEN labeled vials in both the active and waste areas, he concluded that many of the vials had been recycled. The recycled vials displayed clear signs of multiple punctures in their diaphram covers and claims that repeated puncturing of the diaphram will eventually lead to excessive Xenon-133 leakage. . 2. orric<>..........................................:...._......................i.J............./..n....... c..'............ suauwcp...................................................................... om),...........................................................:............................:............

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DOCUMENT 4 Memorandum of February 28 and 29,1980, telephone conversations with Chief Technician, St. Luke's Hospital. said that for at least several years preceding September 10, 1979, all-stocks of Xenon-133 purchased by St. Luke's was supplied by NPI, Milwaukee. She said that St. Luke's,could provide confimatory documents, if necessary. DOCUMENT 5 February 22, 1980, statement by Phamacist. EsZ ~] states that he was employed as a phamacist for NPI from July 1976 through September 1977. This employment was first in Texas and then in Kentucky (both are agreement states). While in Texas he was trained by in breaking down bulk Union Carbide Xenon-133 and inserting it, for distribution, into used NEN vials. It was sold to hospitals for inhalation studies in humans. Some documents accompanying the Union Carbide Xenon-133 were marked, in effect, "For research use only. Not for human use." When M auestioned NPI's distribution of this product he was told it was safe for use in humans and not to concern himself with the matter. Vials were recycled so many times that leakage became a problem and in a matter of hours some vials were found to have lost up to half their activity, rather than just the stated that if he few ten,ths of a millicurie from nomal decay. were a hospital technician and received Xenon-133 in an NEN vial, he would assume the Xenon-133 to be a product of NEN. He said that breaking down and reselling Union Carbide Xenon-133 was very profitable, much more so than just buying and reselling vials of NEN's Xenon-133. ,.4.. .s l:...'........... .... ~............ orrsetb...................................................................'. SURNAME DAT[k.........,.........................................<........................................Z~...l...

I 4-Mr. Julian Greenspun 3.. DOCUMENT 6 Report of February 21 and 22,1980, interview of " ' rough drafted on February 27 and reviewed in final on March 7, 8.

said that when told him that Union Carbide Xenon-133 was fit for human use, he had to assume was correct. He said that he was new (recently graduated) and assumed that his employers knew what they were doing. M said that he knew that to be suitable for human use, Union Carbide Xenon-133 had to be approved by the Food and Drug Administration and NRC or state-approved.

Based on what his enployers told him, he assumed tnese approvals existed. He also said that in his present employment, with another nuclear phannacy, the refilling of NEN vials would not be considered ethical. .D._O. CUMENT 7 March 21,1980, statement of Senior Licensing Reviewer, ^ Medical and Academic Section, Material Licensing Branch, Division of Fuel Cycle and Material Safety. Office of Nuclear Material Safety and Safegtiards, NRC. M states that she is responsible for the review of applications I for new licenses! amendments, and renewals to licenses, and is authorized to act for the NRC in granting licenses. In her off'fcfal capacity she has often reviewed NPI Milwaukee's NRC Materfals License which was issued to NPI under the effective date of May 25, 1977. Its issuance was based, in part, on commitments made to the NRC by NPI, Milwaukee, in en April 29, 1977 letter which stated what its " Procedure for Routine Use of Xenon-133" would be. These commitments preclude the recycling of - vials for single dose quantities of Xenon-133. "_' ~ , ', :..h b:y: i.; a n;:._. :.. ^. ~ .,( t. g.%:..i.. ~ 7;,n - ~ ~. orncEk.............................. 4.,....y......... ..t.* SURNAME o^i e >..................

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Mr. Julian Greenspun W-DOCUMENT 8 March 21,1980, statement oECMMANN Licensing Specialist, Medical and Academic Section, Material Licensing Branch, Division of Fuel Cycle and Material Safety Office of Nuclear Materials Safety and Safeguards, NRC. UME ] states that on occasion he has reviewed NPI, Milwaukee's license file in connection with his official responsibilities. He said that in support of its efforts to obtain licensure of its Milwaukee, Wisconsin, phamacy for the handling of Xenon-133, NPI made commitments for the. packaging and dispensing of single dose quantities of Xenon-133. He said NPI indicated that the vials it used for single dose quantities of Xenon-133 would not be recollected and reused for dispensing purposes. To pemit such recycling would require some operation that would neutralfre' and free the vial from pyrogens, as well as provide a new leak proof rubber or latex seal. If such an operation were to be conducted, it should have been addressed and further explained by NPI during the application process. DOCUMENT 9 April 8,1980, s atement ofEMha=2 ) Ph.D. (Bionucleonics), Registered Pharmacist, Radiophamaceutical consultant. states that from October 1978 through December 3,1979, he was emp}oyed by NPI as Regional Director of the Midwest Region (Illinois and Wisconsin). Although he had the title of Regional Director, he really perfomed as the nunager of NPI's Chicago facility and managed NPI's Milwaukee operation, hPI was very profit oriented and .f ~., L ( .,. V ;., ~.. : z.-..... .. T : ... : :--..,.. u....:,..,+.:.'s. :..,..:r.: q ie.; -.......- :. [ .. :. ~ W ij % : Q.j f d.Q ijf M, % e.' <. 9- - ^ 'p--;;c e ;: :u.... 1 - 3.:. ' '. -w.t o r r o e e >

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l Mr. Julian Greenspun, NPI's central office applied continuous pressure to cut costs and increase f prafits. Toward this end, HPI' proposed that W 2 3do ~ something which considered illegal and unethical. It involved deceiving NPI's hospital customers regarding the source of a particular drug. Taj refused. Part of the money-making pressure applied by NPI's central office involved the breaking down of Union Carbide Xenon-133 into dosage units for sale to hospitals for human use. Between approximately October 1978 and January 1979, NPI Chicago handled six or seven shipments of Union Carbide. It was sold as is (not broken down) to a single hospital. did not view NPI Chicago's NRC Nuclear Materials License until about a week after a January 1979 NRC inspection. When he read Condition 15 of that license, it was absolutely clear to him that NPI was in violation of that Condition by buying Xenon-133 from a source which did not have an ' approved NDA and selling it for human use..He feels that NPI officials, who had copies of the license, should have realized this. % has no idea why, from the beginning of his employment, he did not have a copy of HPI Chicago's license. From the beginning he requested one from NPI's President, who only had to send it to him. When he took over management of NPI Chicago, found things to be chaotic and he did not have a copy of his license. He found many radiological safety tests were not being perfonned that, it subsequently developed, were NRC license requirements. S .y.... g. ..-.+ r.,. .u. ,[,' J.-.'

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Mr. Julian Greenspun > i Note: From the above and from inforuation which will be summarized l , clear that if E had a copy of I elsewhere in this package, it seem NPI Chicago's NRC license at the time he assum'ed his official duties, there are things 'he would not'have done which, in turn, muld have resulted in decreased profits for,NPI.

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Nuclear Materials 1.icense and recognized the language in license condition i W e being typical of the language in NPI Chicago's license. Therefore, in his statement of April 8 he makes reference to " Condition 15." The language he was referring to, which is contained.in NPI Milwaukee's license Condition TS, is actually con.tained f.n licensa condition 16 of NPI Chicago's license. DOCUMENT 10 ' ~~ March 1 1980 Memorandum fo from This memorandum researches the issue of whether willful violation of 10-CFR 19.11 (failure of NPI Chicago to have on hand and posted a copy of. their NRC license) can lead to legal sanctions. The writer concludes. . c... 3 that willful failure to post its NP.C license (and by inference to have it on hand) could be criminally prosecuted.under Section 223 of'the ~ Atomic Enargy Act (42 USC 2273). 9 ^ 'y.-yygg; ,',,,;.,q:4.. ~ , 7.. c ' c ' " d '.'. + c . h..g *.'..'.'., *, ..,. _.. w ; ; g... ;. g......,,;A.r,, g.,.w g,,...,,_, , # ;. ~ .. '  ;. 7 %, *.'.gq ~ eg.,,Ch '.~.{.;"y ;. '.. .M." v f:.*.'*,.. . p" M.P' % ' ?,'l.'. ' 4 8...... .g.. ',3..

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8-Mr. Julian Greenspun e 1 DOCUMEHT 11 ~;; on 4 a r+,,wv 13 14, and March 11,1980, interviews of l EFEBRAMl rou,gh drafted on March 3, 4, and 17 and reviewed in final on March 25, 1980. F4Flsaid that NPI Chicago generally ordered through NPI Headquarters f and the goods were shipped directly to NPI Chicago by the manufacturer. One exception involved bulk Union Carbide Xenon-133 which, as well as He some Medi-Physics Xenon-133 (unit dose), came from NPI Milwaukee. said that NPI Milwaukee broke down bulk Xenon-133 into syringe doses, as well as into vials. He admitted that at infrequent times HPI Chicago ran out of 2 ml. vials and reused some, but never NEN's. He said that breaking down bulk Xenon-133 into dosage units is very profitable, as opposed to buying and then selling the prepackaged single dosage units. DOCUMENT 12 Report of February 12, 1980, interview of ' rough drafted on March 6 and reviewed in final on rc 80. 1 @ a radiophamacist, worked for NPI Chicago from November 1978 l through January 19, 1980. In pril 1979, Regional Director, madM the Manager of the Chica90 Office and he maintained that l title until his resignation. Shortly after he began working for NPI and prior to the Janu::ry 1979 inspection of NPI Chicago by NRC, about eight bulk shipments of Union Carbide Xenon-133 were received which went, as received, directly to one hospital. said NPI Chicago picked up radioactive waste from its customers. This included waste Xenon-133 '.:./'.. single dosage unit vials. About 80-90% of these vials were disposed of;, -u. The remainder were refilled by NPI Chicago because there were no new TSW'i ".' .5.R.,. f. .~ ' z/[, j p.,

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Mr. Julian Greenspun ..x vials available at the time. EAM Lsaid that he never reused NEN =. - ~ vials and does not believe his fellow radiophannacists did either. He said that refilling was inferm.ll.y discussed among the staff and it was the concensus that "it would be unethical".to refill NEN vials becau'se they had pennanent HEN labeling on them. When became Office Hanager he read NPI Chicago's NRC license. It became clear to him that since Union Carbide's Xenon-133 did not have an NDA, dispensing it for human use would be in violation of NPI's NRC license. DOCUMENT 13 April 9,1980, Memorandum for File by This memorandum shows that NPI Chicago was not ifcensed by NRC to receive., acquire, possess, or transfer Xenon-133 until November 16, 1978. Despite this, a January 31-February 2,1979, NRC inspection found NPI to have procured "Not for Human Use" Xenon-133 (Union Carbide's) on at least seven 'eccasions between October 12.-1978 (before the effective date of the lkense) and January 12, 1979. Purchasing Xenon-133 in the absence... - ... ; r.q:, ' 1. m .m of licensed authorization is in violation of 30.3 of 10 CFR.' 5.. - ~ Note: Not only was NPI in violation of a license condition prohibiting its acquisition of Xenon-133 intended for human use, from a non-NDA _. w ~ source, but prior to November 16, 1978, it was not licensed to rece.ive,' acquire, etc. any Xenon-133. Additional data indicates that between June 6,1978, and October 12, 1978 NPI Chicago received Medi-Physics...J.9 M.. u.'.:' 9.e.;.E E.S.h.. m.::w.-,c.g. :-.= e c. _ c. /.p;a prepackaged single dose Xenon-133 funits on,at least.17. ' separate occasions.te.... .. m .~.=..y.,;. y;p.. : au... ....,.....3 : g..

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Mr. Julian Greenspun =.. - DOCUMENT 14 April 8,1980, letter from fomer NRC employee, to Office of Inspector and Auditor. In his letter,E who conducted the NRC's January 31 and February 2,1979, inspection of NPI Chicago, furnished infomation from his notes which show that NPI Chicago received at least 19 shipments of Xenon-133 before November 16, 1978. At least two of these shipments were from NPI Milwaukee. Note: Since NPI Milwaukee was authorized only to transfer nuclear material to licensed recipients, its failure to restrict itself to such transfers was violative of s30.41(b)(5) and $30.41(d) of 10 CFR. DOCUMENT 15 March 19,1980, statement of i'L M c D Radiophamacist. h states that from August 1977 through October 1978 he was employed as a radiophamacist with NPI, Milwaukee, Wisconsin., NPI Milwaukee's instructed him in breaking down Union Carbide 1 .J-

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labeling on the outer container of Union Carbihe's Xeno 133, E _ became concerned about its suitability for human use. He expressed his-concern to g said that the other NPI radiopharmacies were using Union Carbide Xenon-133, so it must be O.K. Nisaid that the;-- Xenon-133 which NPI broke down went to hospital customers who used it' for lung ventilations for human patient $.. 'NPI did not test it for...,. _.. _ _,., ~ 3y . ~ _ _ .:.-......n.e .n. radionuclidic purity. While employed by NPI.Mnever carefully red...I%,: ;. ' M : c.6. n...,;j.: p;D.: m : ' ~.,a y: c.. r-... 2 NPI's NRC Nuclear !bterials License. He said that.upon being'shown'a '.'E f'2 4 '

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Mr. Julian Greenspun. =. -. copy of it and reading Condition 15, it became clear that Union Carbide's m.. -..~ Xenon-133 was not indicated for human use. He knew from prior work experience that Union Carbide did not. have an NDA. With the exceptfon of a small amount of Medi-Physics single dosage unit Xenon-133, virtually all of the Xenon-133 gas handled duringgs time with NPI was from Union Carbide. Eighty percent was broken down and the rest was sold in bulk to hospitals. Union Carbide's Xenon-133 was much cheaper than the other available source of bulk Xenon-133. The vials used for unit dose dispensing were often reused many times. % instructed %to put vaseline on the rubbgr septas or they would leak. They were penetrated as many as 100 to 200 times each. The vials were reused until the septum tore. In some cases, it broke loose frem the crimp seal. Some had so many holes that they even leaked badly with vaseline on them. The combination of vaseline and quick delivery, in.Q's judgement, probably kept v.f als from leaking to a point where the validity of a. lung scan was jeopardized. Efelt it was poor practice to reuse these vials and.. that such practice could result M problems of contamination. During 7 ..! 7-the period of his employment, NPI Hilwaukee was often in violation 0 Wisconsin State Phannacy Board requirements and gave instructions designed to mislead the Board's inspectors so they would not learn of- ~ NPI's noncompliance. ~ s. .i.

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12 - Mr. Julian Greenspun l._... ~ =.. DOCUMENT 16 n Report of March 14,18, and 19,1980, interview ofF M @ f* M rough I drafted on March 25 and reviewed in final on April 1,1980. y said that NPI Milwaukee was frugal at the expense of following good phamacy practices. He said that there was a great profit in buying and reselling Union Carbide Xenon-133 as distinct from buying Xenon-133 from the approved source of bulk Xenon-133. Xenon-133, which i i was broken down for dispensing in unit doses, was distributed in syringe.s and vials. The quantities of Xenon-133 used, plus the amount NPI needed for itself, were such that on the day NPI received its bulk Union Carbide Xenon-133, its possession would have exceeded license reauirements. ~ DOCUMENT 17 April 23,1975, letter from milis4kiK M T W E.;,%c. M to Remme f NRC. ~ na This letter, among other things, contains NPI's commitments to the NRC for the ordering of radioactive materials..It shows that NPI was knowledgeable 7 of, and sensitive to, the fact that it could have no more radioactive". ? . :.,m.;.;..,.,2.,,..:... w: ...., v. material on hand:that was specifically pennitted by its NRC radioactive;^..E.". ..j '[ material license (see 7 b. through'e. on page 2). ~ This letter was incorporated ' nto license Condition 17 and failure.j f,2 V i Note: WW.cc'r..i.2 to abide by this commitment would be considered a license violation." 7 .* -f,, - ; ..... [. i + k.. ,.,.aTy, $y

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DOCUMENT 18 March 4,1980 Mcmoran'dum for File by. This memorandu$i [:ontains a February 27, 1980, letter from fonner NRC employeeEwho conducted the January 1979 inspection at NPI Milwaukee. During that inspection NPI's manager, furnished - %with a vial whicM said was representative of unit dose vials containing Xenon-133 furnished by NPI Hilwaukee to its customers. When%left NRC's employ, he gave the above referenced vial to Chief, Paterials Radiological Protection Section fl. HRC, Chicago, Illinois. On February 28, 1980, confirmed receipt of the vial and agreed to maintain custody of it until such time as it might be needed. .h-Mhas advised that the vial does not bear any labeling Note: 4... e ..,,, Q- ' :, and that it doe's'.n'ot"show signs of having been recycled.T-o - a m.Wji@9 : 4 ..:. m:, r... _ z. 1 .. ~. l ~.

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==;* DOCUMENT 19 April 2,1980, statement ofh2WP..f, Senior Licensing Reviewer, z. ., x. NRC. j states that NPI, in letters to the NRC dated March 18, 1975, .. +. and April 29, 1977, made canmitments regarding its treatment and preparation c of all glassware, vials, rubber closures, etc. used in the preparation - and storage of radiophannaceuticals and for the receipt, handling, packaging, etc. of Xenon-133. These conmitments were incorporated into license Condition 17 of HPI Milwaukee's Nuclear Materials License. It ? p.s. 1 opinion that NPI Milwauk'ee would be in violation of its e is .,, c J license Condition 17 if it were to collect and recycle the vials it uses; -, to package single dose quantities of Xenon-133., - j advises that prior to April 27, 1978, NPI Milwaukee was not licensed to pick up and dispose of radioactive wastes (to include Xeno,n vials) from its customers ~. ; ;,.. - = and alDecember.23,1977, letter from NPI is 'available tditch cicarly:- . ;... 2.. :.. ...... wm. shows that NPI knew this. License Condition 18, the amendment to NPI's %:; ~ 5 ,- ;;c::.5,,ily.y:_ __, ..w.;;; KM;p'.:4 zh.... 3.:.<* .7.; license which pennitted NPI to initiate the pick-up of wastes from its Ni'my' custane'rs, only allowed the waste,to be disposed of - not to be recycledp:.~ ,.+ - ~- - = - DOCUMENT 20_ y. April 9,1980, statenent of ;( - _17 7'&- Ph.D., Supervisory Chemist, Division of Oncology and RadiophamaceuQca[l Drug Products., Bureau of.W. W..- -;2-ii~;;. ('. ~ Drugs, Food and Drug Admin'istration., Dr. n. states that as paft of her' official duties she reviews NDd,N_.- a. ,;; _v p ~ f- ...... _ : -.... r :..c: ;;.... : - applications and IND' notices and makes' reconnendations on their approyability.w- ~~ ~ 9.#. t - -:. W M y f M ye. W W C e l}f.s, g *d +.. W...:. :r.-/.- -. ;p 3g ',.pp. y.,.:. She said that Xenon-133 is considered by the FDAM-i.f:Rw - or non-approvability.

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1 Mr. Julian Greenspun. .. =. ai.- W a=- : f .~ an NDA approval. She said that Union Carbide manufactures Xenon-133, i She advised that Union Carbide but does not have an approved HDA for it. provided their Xenon-133 product specifications to FDA and that these specifications are in FDA's Drug Master File (DMF). She explained that having a company's product specifications in FDA's DMF simply is not indicative of the products suitability for use as a radiophamaceutical. She said that Xenon-133 has radioactive and non-radioactive impurities. A company with an NDA must guarantee their product's minimum Xenon-133 and maximum impurities. Union Carbide is not required to make this guarantee, nor do they. She said that without this guarantee, there can be no assurance that a person being diagnosed might not suffer various adverse effects, including misdiagnosis and possibly unnecessary radiation She emphasized that Union Carbide's Xenon-133 would be considered exposure. not suitable by the FDA for use in humans as a radiophamaceutical. For ..n medical use, it~ dould only be provided' to recipients having either an- - % :%. ~-.. :.,- w~ . T. ~

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Mr.' Julian Greenspun.. la., 3 m.--,...... DOCUMENT 21 -r ] April 9,1980, statement of M.D., Group Leader, Radiophamaceutical Drug Products, Division of Onco ogy adiophamaceutical Drug Products, Office of New Drug Evaluation, Bureau of Drugs, FDA. m states that he h$s reIieNd'Dr.Ns April 9 statement and ~ e Dr. 3 L..

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17 - Mr. Julian Greenspun "W ~. ~ -., l In addition to the hbove documents, which were obtained through the * ~ direct investigative efforts of our office (0IA), a number of other documents were gathered from elsewhere within NRC which tend to support.... These many of the statements and reports of interview referenced above. documents follow: a. -,,. < ~. ..; ~,,. .n... ~.. -...>.. s.sg.= :.;w. r, +.:.: :.r n... w. .s .w, .m..,. .....s..<,.. .. -,u.. .~_-M..',.

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Mr. Julian Greenspun. ~ _ -. DOCUMEliT 22 _o. February 19, 1980, letter fran l W:1- [, Director,liRC's ~p, -~ Office of Inspection and Enforcement, tolYWNi- ' ] .. r 72.,. r..- HPI's President. ~ ~.. - This letter advises that during a January 22, 1980, liRC inspection of' +,,... _ - the Elfreth Alley, Apothecary, a subsidiary of fiPI, items of noncompliance. were noted which demonstrate that, licensed activities are not conducted with concern for the health and safety of employees. Attached to the-letter is a liotice of kioia. tion anii a..oIice 'of Proposed Imposition o'f. ,. y... : -. ~ Civil Penalties in the $nount of $4,000. - '. ' c ~ -~ DOCUMEllT 23 ~ -~ ], Director, Office of Inspection ' Parch 10,1980 letter t =.u S. - 2 .J, an attorney representing f4PI. 1 and Enforcenent, fran m This letter challenges the validity of one of the findings referenced in. the fiRC's liotice of Violation, but despite the challenge, forwards a - check in the amount of $4,000 in full payment of [he tuo proposed civil. . ' =,,,_K T:X [M. N: N P.: y .l ;h _ gy:i 'zc ~ :.,. - e '-' ' T 1.\\ 4 cF penalties. ...- N. ".. < % '... ~l57'a.'..A ~ 'a .:. c;.

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DOCUMEIIT 24..s,..',l,f.::.C.:. C.. $. N.. U.,~.5 O Y =...' ". .L ~ ..%. l,' , ?, 'f UYC W. a. '.NM'? E ' t* . w ; *.._., ' : E. '. ' :.C. e j (* z c, n. '"~ ~ ~' - ' P e. M April 1,1980 ' s' atenen't'of7 ~ ' " ;_J, l icens ed Phannacist' '.T 4.i.' *.1. dt,.'....,. t .. u.r.. states,tliat he was employed by llPI l'hilad lh. .. e.... ia Elfreth Ali '5Y.k. ...i"4.-s...,..t~... 2 a n . q. 3...... ..i. _.J. ]. _ ll .v.. -,-, ~ During this.~h. v[.,.c Apothecary) fran April,9.1979, thiough lbrch 14, 1980. .... s. ~. -.. caplo ent, he served as Assistant"1.aboratory Manager fran..Decc.nber.19. 7.9.: ;;i r. ... ~ .The[ranainder of the time hd seived as.h b. _...,.. m... - p... .....s...... .,3., f.... s.- through February. 14, 1980. _ -.....,' ~. ~ 'YI'f M' ' ..,s,,nmr. s'hpun a copy of ilPI's liRC licens'e1c...a ~ ... g'..... phamacist*f '. ' ' said I F L* - ,. < ~...y.;,a n.:... ?- .,... ~... ............ ~..... v~ y~. y r;~~&;,?. -m. f-Q:[..,;[E;%p.H.WQ :; .....,.:. :,'j'.: %,? ;.%q: n.,w -;,,.. ;;~., m.d.... f}Mg.p..M..'%.g.; -- gy..g-s.::.g.9;. ;,.y; . r. ' c: ~ ':. .w..m t.~ C. . :y}W, i.c .. -. a.: .. 2.,,,;;...,,,m. .3 Y ~* ~ y. .,4 :. '.N. ?.g.7,',; .n.

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Mr. Julian Greenspun,. h.C ' and was never made aware of its various conditions. After working for - n. *. - i : u NPI for a short period of time he observed that safety practices and .~. procedures were often non-existent or basically inadequate. 'He learned ~ .a: - that, despite the fact that certain required proce'dures were not carried = .x out, documents were prepared to fraudulently indicate that such procedures ~ 8 had been followed. 1 ( [ DOCUMENT 25 ~ dated Report of April 8 and 9,1980, interview of April 10,1980. Q,.-- . ; 7c. l g - said that until Decmber 1979, NPI purchased bulk Xenon-133..... frcm GE (General Electric) for t.reaking down and dispe'nsing in unit doses. Fra Deceber lh9 through the end of his employment with NPI, Xenon-133 was purchased in prepackaged individual doses from NEN. @ ' knew of two instances where HEN vials were returned from hospitals for' i ~ s 1 disposal, but instead, were refilled becaus.e..some..activ.ity.re,ma,ined int . *,.. g t.l e. ~,.,s ' ' _ d.y:..M T 2 *g * * *:".. n. ' ,..je;. ,, s. thm. ~..: l * %... i . ::.X.,W..W::.=.. L J MW.,. W.R. y. 'L. _.. i .z..,...... bd b I...M N, D... b.n ;;.N.. r.bkd'I. N N. ..e. 5. ~.... y. ,r.. .n2 DOCl*ENT 26 L....: 7,; p.9. y j.f. _.,. M. . s.u : .. rs &. NTC Section Leader,=.p w ;;5.." p Memorandum of March ~26,1980, f Regional Licensing Section, to _ W,. Chief, Material Licensing'Qpp ~. .,..7.e,.,.~., ?.{ .,g', .'. F.. -......C,-. Branch, NRC. ^.n. L. -; g c.onducted J.. This memorandum pertains.to a post licensing visit which ,.. z...;..;,. .r, .. 9 ;..a...::,,.a.. w..- + -. .-..u -. ~, - ~ in conjunction with an.IE inspection of NPI Chicago. In it he identifiesife'gt,9, .e.:. q. p.. s 7 :. . g. - ~. m...c... g y.~4 _v.. L. ~ numerous possible license violations and in item 3.a. on page '4, he .~. T.'M ".. l ~ \\ ide'ntifies a phamaceutically unacceptable practice which is also addressed. ~ ... w..w..t.,.. -..y,.... ...c..... 01..,, ...,...,.? m... a.... -, . u r.w,a. a g%. y...,. g. g g w-m m.;c . b..Z,c;..e

m. lW 6 on page 3 of the !brch 18 and 19..,1980,'interv.iew o.

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1 + ~ l. Mr. Julian Greenspun 20 - b. in his interview, depicted the frugality of Wh..., Document No.16.) ~. - e 7.~. . NPI Milwaukee's, management by showing how NPI routinely tried to save .3. .,.-? :..: : e.: -:.y..... $.30 at the possible expense of,.contam.inating an injectable solution. . J ~.. r q c.: : ~..+. :.;'.:c... eW.. L JM ..a.'_ '. Ji~, :. t. .,..u.... DOCUMENT 27 w

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- y 7.: <.... ~, March 20,1980,..P,emorandum to Region III Files frC #VW], i. Region III Investigations Specialist.. ,. ~..... . c, g ~. .e ~. m.. This memorandum pertains to the Parch 12, 1980, interview oficz.i -+, claimed to have been. enpaoyed from January 1,1980, to Parch 6,1980, .-.-*--i According to the memorandum, { served as a laboratory by NPI Chicago. technician.. Although he. worked in' a high radiation area,'he had never been supplied with a required film badge which measures radiation exposure. j allegedly claimed that during the NRC inspection of NPI Chicago,- -{ ~ during the week of February 25,1980, != was given the film badge assigned The reason he was provided with' the driver's badge to an NPI driver. w .a. was to prevent the NRC inspectors.from finding out that QL..radnot:.3..[.. . - ~..r .p. . ? ~. %; ',. 1-

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g. 6 - c'u 'ir. [. M ,.,:--.; p i..., - been p'rovided with his,own badge.;g..N' , ~-. . e r. --se., ^:. ' y -.... y' ~~ : '.;y:,e'. :.. - 2..' M:-:~w.. ;.Q~;. .. i' G ).",i : a :.. .v.. w..,..? u..,,.,. w.. * ~ 7 f 3.QK. h b,...'. 2....'.'. $ m-;. C y:y %. : t 3_ p. m_ ..q

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n. :... 7; - -;M. in a high radiation area,.H.P.I's. fail.ure to provide him with a radiation,t. 9.. ;T.. 'i?. badge.makes it impossi..ble to.,detemine to what extent he may have been r.. !E.. l.P........ .... -.n e.v :7.'..:. .... w a :k..-: .. c.;..-- - u x- .:. : ~,..: : By providingsta :.;M..

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  • ~2, NRC inspectors during their February:.1980 inspection, any radiation,that.7/d.;.,:.2.

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21 - Mr. Julian Greenspun t .A._ M.a.. We are keeping all original statements on file; however, they are available if and when you should need them. If you have any questions about this J ' package, please contact Jerry Strickler (492-7170). m..;. C,.,.'~.,..;; ..h f.- g,. Sincerely,... .L...,. .g..- 4. g *,4.. -... c*. ,e >P. n .t ...: g. '.L ; w.,, y,..*,, : 4.. pu f.- *.,,;g *4. g =. , = - c, : Off.-7 ' odgbalSignedby.. i T. ". ;'. f...(. Rogerfatuaa e ' - ?. ':..L.. Roger A. Fortuna,' Assistant Director .~ . ' M-N for Investigations ( ~ Office of Inspector and Auditor L -L .y

Enclosures:

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