ML20207Q394
| ML20207Q394 | |
| Person / Time | |
|---|---|
| Issue date: | 10/02/1984 |
| From: | James Keppler NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Dircks W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| Shared Package | |
| ML20207Q383 | List: |
| References | |
| FOIA-84-856 NUDOCS 8701270270 | |
| Download: ML20207Q394 (4) | |
Text
{{#Wiki_filter:- 4
- it..
- '] TNA ^r % % nass /% 5-e undio:Tariis c. .3, Rg y f NUCLEAR REGULATORY COMMISSION HAM
- D C 30**
e $ Cy q \\....w ".9.
- octosr2,1984
_._y (e. t o. %, 3,) 9 Q,p s. ItE bet, 5 Md. we. A eall N '"i C.qde Hin % epamv m eM MEMORANDUM FOR. William J. Direks. Executive Director % or Operati 9tMib. k u. Mechwj. t f s FROM: James G. Keppler, Regional Administrator W 4
SUBJECT:
. DRAFT MEMORANDiM TO THE COMISSIONERS - REGARDING NUCLEAR PHARMACY, INC. -ri Y-Enclosed is a draft, memo for your signature, infonsin the Commission of our intenkih suspend operations oI six nuclear pha cies and 01%er to Show Cause whfhclear Phannacyr Inc. licenses should be revoked, ?. Original Si By: /^ ff James G. 1er ) /f/ 'i Regional inistrator /* V p q60 ,4 p. !!![, ...t. a =" koplagg o $70120 CAMpggg4'806 PDR _? ..e. l
- e*
62
- ~
~
s t '..
- 3* '
] DRAFT
- y. :y:ll:
wr M :: ) l .:w t 1 c: NEMORANDUM FOR3 The Connissioners '.t. : i.,f i FROM: William J. Dircks. Executive Director for Operations '3 $i.: -{ { ESCALATED ENFORCEMENf. BRIEFING - NUCLEAR PH
SUBJECT:
,....u This is to infonn you of the staff's,,4ntent to take escalated anforcement ..n e, action against:: Nuclear Phamacyt Inc. A.. N.P.I.). The action presently con-templated invi/ives trenediate suspension and an Order to Show Cause why six N.P.I. licenset should not be riivoke[,. Nuclear Phartinhy. Inc. produces,and distributes radiopharmaceuticals to thousands of'.hdspitals throughodt the, country for diagnostic testing and therapeuticpupses. M.P.I. has 47 pharmacy licenses; 41 in Agreement States and 6'ufder NRC jurisdiction (three in Region I and three in Region i i III). _E .w- .7 The basis fohh enforcement action is as follows: .q-Due tolhe licensee's failure to. perform required quality control tests, 1. pharmacesitcals significantly contaminated with radioactive impurities v:. wer1e diitributed and adninistered to 12 patients in the Chicago area during Mity 19-21, 1984. The coniaminated esos resulted in these patients' receiving radiation exposures about 10-15 times what they should have, and interfered with their-diagnostic tests.
t \\ DRAFT E.: ~ The ComissicNMPs -2
- m
!.8 {.'c The NRC';s,' investigation into the:sontamination incident disclosed the 2. followin'ij ~ The-U1censee, including its hnior Management, mislead the a.
- .e MRC:;o,n numerous occasions concerning the seriousness of the problem.
TheM was first told that;no contaminated pharmaceuticals were dis #1buted to hospitals ard later that no patients had been injected .. ~ with 'the contaminated pharuiiceuticals. ~. b. Rec 6rds were falsified regarding the required quality control checks 4 to #4 perforned. -? . u. c. The allure to perform the required quality contml checks and/or the 3 fallii.fication of records app _ ears to be generic (based on inspections of of the 6 NRC lice.nses).# s.. \\ d. The:1.icensee was still failing to perform the required quality control chee,ks as of late August. b..u The ispect ( tting down the.six hiear Pharmacy facilities on the medical 1 i community has', Ween considered and appe_.ars to be minimal---other companies i; supplying radiopharmaceuticals can make up the shortage; however, it is anti-cipated the rispension of licensed aciivities will be contested vigorously. ..s 2 %g a..:
DRMT e The Commissi et 3 !.2u;
- r '
The 0! investigation is still ongoing. The involved Agreement states have been i: alerted to thi problems (but not the NRC's planned actions). i:..- I believe the]Comission should be infonned of the details of this case before e: the staff inf.tiates its action. I woGld like to have this briefing conducted following ths'.Comissica Callaway meeting on October 4,1964, if' that is ii acceptable to.the Comissioners. Because the OI investigation is gt.111 ongoing, I rdhomend this briefing be closed.
- [
i ..,y. a 5: .i r . William J. Dircks r; ,- Executive Director for Operations 1 ~. i-Q t:
- i
.I l ~ l .W t i;::. j! ![ ~ , -.. -_ _ _ _}}