ML20236U477
| ML20236U477 | |
| Person / Time | |
|---|---|
| Issue date: | 07/30/1975 |
| From: | Jennifer Davis, Dreher F, Thornburg H NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | |
| References | |
| PN-75-060, PN-75-60, NUDOCS 9807300189 | |
| Download: ML20236U477 (1) | |
Text
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PRELIMINARY NOTIFICATION - NOT FOR PUBLIC DISCLOSURE July 30, 1973
(%d PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE
--PN-75-60 1,
i This preliminary notification constitutes EARLY notice of events of POSSIBLE safety or public interest significance. The information presented is as initially received without verification or evaluation and is basically all that is known by OIE staff as of 11:00 a.m. on the date of this notification.
IT SHOULD BE SPECIFICALLY NOTED THAT THIS NOTIFICATION MAY CONTAIN INFORMATION THAT LATER MAY BE DETERMINED TO BE INACCURATE OR INCONSISTENT. AN OFFICE OF INSPECTION AND Eh70RCEMENT NOTIFICATION OF AN INCIDENT OR OCCURRENCE (BLUE SHEET) SUBSEQUENTLY WILL BE ISSUED IF WARRANTED.
.. Facility:.CIS Radiopharamaceuticals, Inc. (License No. 20-13695-01)
Bedford, Massachusetts
Subject:
FDA INJUNCTION - SHUTDOWN OF OPEPATIONS Region I was inf ormed on July 30 that CIS Radiopharmaceuticals, Inc. had ceased all deliveries of radiopharmaceuticals on July 30 as a result of an FDA injunction.
Apparently, the shutdown came without advance notifi-cation and will severely hamper the nuclear medicine programs at several hundred New England hospitals.
e
_.,_ Region I was also informed that in at least one case, VA Hospital in Providence, CIS had erroneously not,1fied the hospital that the injunction was an NRC action.
(This misinformation has been corrected).
Significant
(~
enforcement actions have been taken by NRC, including a Civil Penalty, over the past year.
A Region I inspection on July 9, 1975, revealed substantive improvements.
CIS was found to be in compliance with NRC license requirements.
Media interest is expected because of impact on nuclear medicine in the g']
New England area.
The State of Massachusetts has been informed. Other New England states are also being informed. A press release is not planned.
OIE (Region I) received notification of this occurrence by telephone from NRC HQ - Public Affairs at 9:00 c.m. on July 30, 1975. Public Affairs had just received a call from a physician from Providence, Rhode Island.
Contact:
FADreher, IE x7261 HDThornbuyg, IE x7353 JGDavis, IE x7541 5
fa.
Distribwt-ion :
Chairman Anders Commissioner Mason S. J. Chilk, SECY g
Commissioner Gilinsky Commissioner Rowden G. F. Murphy, JCAE Commissioner Kennedy C. C. Kammerer, CA to o "M
L. V. Gossick, EDO
,3{)D.F.Knuth,IE J. A. Harris, PA B. C. Rusche, NRR d H. H. Brown, ISP T. J. McTiernan, AIA N N K. R. Chapman, NMSS H. K. Shapar, ELD Transmitted: P Bldg 2Np ;
H St 2_b ; MNBB 2 Luge m i
i PRELIMINARY NOTIFICATION - NOT FOR PUBLIC DISCLOSURE L____________________________
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