ML20023C850
| ML20023C850 | |
| Person / Time | |
|---|---|
| Issue date: | 02/08/1981 |
| From: | Gamble D NRC OFFICE OF INSPECTOR & AUDITOR (OIA) |
| To: | Strickler L NRC OFFICE OF INSPECTOR & AUDITOR (OIA) |
| Shared Package | |
| ML20023A415 | List:
|
| References | |
| FOIA-82-515 NUDOCS 8305180106 | |
| Download: ML20023C850 (6) | |
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N UC L E A R R E G U L Al O H Y COT.*!.'.'
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Lawrence J. Strickler, Inyestigative 1:anager
.EEMORAtlDUM FDP.:
Office of Inspector and Au,ditor
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Awbd-David H. Gamble, Investiaator TROM:
Office of Inspector and Auditor y,,_ A MEETItO BETWEEN NUCLEAR PHACPACY, INC., AND NRC C
SUBJECT:
JAriUAR( 21, 1980
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As requested by a representative of the Department of Justice (D interviewed Victor Stello, Director, Office of Inspection and Enforce (IE), on February 5,1980, to obtain his' recollection of the Janu (HPI),and meeting between representatives of Nuclear Phamacy, Inc.
k HRC. Also present during the interview, at Stello's request, was Director, Division of fuel facility and Materials Safety Inspection, IE.
Stello said the meeting was precipitated by rumerous telephone calls from flPI Attorney Vakerics who categorized th_e matter as a "no-never-Stello said he told Vakerics mind" issue which IE should not pursue.that he disagreed and it wa condition. '
Stello recalled NPI's asking him whether they considered NPI's actio Stelle said his to represent a danger to public health and safety. rep i
does He said he then demonstrate a danger to public health and safety.
IE is repeated what he had told Vakerics earlier on the telephone:
pursuing a civil penalty ag'ainst NPI; however, if IE thcught NPI's He actions were willful, they would seek a revocation little question, based upon the way the license condition had been Stello said it explained to him, that a civil penalty was warranted.
was clear that NPI's position was that NPI's actions did not endanger public health or safety and he (Stello) immediately " jumped on" cont ention.
Stello recalled there was considerable discussion about He said Vaker?cs claimed it was unclear Sniezek interjected condition did or did not mean.
as to what the intent of the license condition was.that it w
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rom FDA to llPI which discussed the FDA requirements..'
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Dkh$h06830412 OfSHWIL82-S25 PDR ENCLOSURE 1
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>; 7 Stello: recalled NPI President Sancnez mentioned that thev.were
.ouestioned _on this issue -(i.e...where NPI cat its xenon [from) by tht He said Sanchez claimed they stopped this activity in
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Texas after: being notified it was a problem and NPI sent letters to a-
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number'of other states asking whether this' procedure constituted a Stello said he' asked.Sanchez why NPI did not send such a e
" letter to NRC, to which Sanchez replied that he did not think it would problem.
w pose a problem with NRC.- Stello _said he clearly made,the. point to N that, if they have questions, they cannot unilaterally decide them -
they must - come. to NRC for : the-answer.
Stello said the only discussion about xenon itself was-his ' comment that if xenon _is-improperly manufactured the process might allow the introdu of foreign substances into the dr0g; Stello recalled one issue that NPI did not adequately address-was-the
-Stello advised NPI that he understood 'they _had.
labeling of the xenon.
He rem.oved or covered up the Union Carbide. labels on the bulk packages.St said NPI could not give him an answer 'to 'this.
considered this significant to demonstrate NPI's intent.
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Stello said he told NPI that, based upon IE's review, count number two
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He said, of the notice of violation most likely would be dropped.
however, that this decision was not final at the time of the meeting. e r
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.Stello said that he. absolutely did not agree to rethink / rewrite the notice of violation.. ~ except. to the _ extent.that -new facts may develop l
during further evalbation.
Stello said he agreed to Yakerics' request that, when IE is all through preparing the letter and order imposing the civil penalty, NPI could come in and ~ review the package.
At this point Sniezek said there was no i,
agreement that.NPI representatives could come in - just that they discuss the package with NRC's lawyers.
L' recollection, _ but said the point was-that when IE was complete, NP_I could receive some infonnation about the package ahead 'of its issuance.
i Stello confirmed Sniezek's observation that this procedure was common practice.
Stello said the implication was not that NPI would have anyStello s input into the language of the final package.
IE would change the package at that stag'e would be if NPI demonstrated that it contained 'a factual error.
Stello said that, in response to an NPI question about timing of the
. enforcement action, he said IE was taking no action until the D0J reached
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He said he told a conclusion regarding their evaluation of the matter.
them that DOJ had requested IE to wait and he felt obligated to honor He said, in response to NPI's request for estimated i-their request.
completion date of DOJ's action, that he.iust did not know.
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.Both Stello and Sniezek said the only letters or other cocume they recall changing hanos at the meeting were (1) the-1975 letter fro-FDA to NPI which Sniezek gave to NP]:and (2) tne samples of labels whici.
NPJ gave to Sniezel..
Sniezek said the only name that he. recalled being provide'd to NPI was 4
that of Rebecca Woods in. response to Yakerics question as to who was HRC's contact at FDA.
Sniezek could not. recall the affidavit from Halperin (or Halperin's name) being discussed.
Stello could not recall any names being discussed.
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voluntarily caLe the followinc c.t'a tement tc Lawrence J. Strickler, who has identified hiaself to me as an investicator with the Office of Inspector and Auditor, U.S. iluclear Repu'atory Comaission (fiRC).
fio threats, rewards, duress, or promises of any kind have been made to re to obtain this statement.
I have been advised that this statement may be used ir; any administrative or judicial proceedings which may be undertaken by the Government.
I am the:~
of the fluclear l'edicine Department at St. Luke's Hospital in Milwaukee, b'isc. and have worked in this capacity for approxi-mately 10 years.
For some period of time prior to September 1979, St. Luke's purchased Xenon 133 -(Xe 133) from fluclear Pharmacy Inc. (tipi).
It is used as a radiopharmaceutical 'to diagnose conditions of the lung.
It is purchesed by St. Luke's pursuant to a license issued to it by the flRC.
A condition of this license requires that " Radioactive gases as free gas or in solution, to be administered to humans, shall be procured from a supplier who distributes the product indicated for human use in accordance with
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the rederal Food, Drug, and Cosmetic Act."
L'henever. St. Luke's placed an order for Xe 133 with fiPI, it did so under a physician's prescription.
The Xe 133 was received either in ampules (bulk) or in unit doses.
All of the Xe 133 received from f!PI was acco;npanied m
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.t by a prescription label which stated in Part *xxxThis radiopharmacentical is licensed by _the U.S. Nuclear Regulatory Commissionxxx".
J Other than dose calibration, St. Luke's performed no tests on the Xe 133_
it. received.
Ampules of.Xe 133 were used.for the withdrawing and -dispensing of unit doses.
Unit ~ doses were simply dispensed on a unit dose basis.
I can not recall if there was ever any labeling on the Xe 133 received f rom NPI _ that would serve to indicate or to identify its manufacturer.
There was certainly nothing in or on the' labeling to indicate that the Xe 133 was not for human use.
Had -such a label existed, I would have initiated inquiries.
1 As; of the Nuclear Medicine Department, I relied upon NPI, the~
.same as I relied upon our ot er pro ess onal suppliers of pharmaceuticals, h
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to furnish a product that was approved for human use.
This reliance was based on my knowledge that NPI knew that the Xe 133 they were dispensing to us was for diagnostic use in humans.
It was also~ based on my knowledge that NPI was supplying Xe 133, also for diagnostic use in humans, to -
other area hospitals.
Additional assurance came from my knowledge that-NPI was subject to monitoring by the _ Government (Federal and State), as was St. Luke's.
The statement on NPI's prescription label, which I previously' quoted from, certainly could be construed as assurance that its Xe 133 net HRC requirements for use in hunans.
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3n about August of 1979, an article appeared in the li 1wautee Journal
- which advised, in effect, that the NRC had~ cited HPI for supplying local hospitals with Xe 133 that was not approved for human use.
St. Luke's was one of-the local hospitals centioned in the article. Until.that article appeared, I had no idea that NPI had been charged by-the NRC for allegedly shipping " pharmaceutically unrefined" Xe 133. I think that NPI should have notified its customers of such charges before the article appeared-in the press.
Since..about Septe:nber 1979, St. Luke's has not ordered Xe 133 from NPI.
In October 1979, I was contacted several times (both by telephone and letter) by an attorney who was representing fiPI before the NRC.
He wanted me and a member of my staff to provide some assistance to his client. We did not do so.
I have carefully read the foregoing statement consisting of 8 pages, f
I each of which I 'have initialed.
I have made any corrections shown and y
have placed my initials opposite each correction.
The statement is-f true, accurate, and co:nplete to the best of my knowledge and belief.
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Feb. 13, 1980 Witness:
Laurence J. Strickler 2/13/80 Audrey 1:ontonicz 2/13/80 e