ML19257D458
| ML19257D458 | |
| Person / Time | |
|---|---|
| Issue date: | 01/10/1980 |
| From: | Brockett T, Gower G NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | |
| References | |
| EN-79-011A, EN-79-11A, NUDOCS 8002040433 | |
| Download: ML19257D458 (2) | |
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JANUARY 10, 1980 0FFICE OF INSPECTION AND ENFORCEMENT EN-79-11A NOTIFICATION OF SIGNIFICANT ENFORCEMENT ACTION Licensee: Diagnostic Isotopes, Incorporated, Bloomfield, NJ License Nos. 29-13985-01 & 29-13985-04MD
Subject:
PROPOSED IMPOSITION OF A' CIVIL PENALTY - $500 By EN-79-11, dated October 10, 1979, the Commission was notified of the intent of IE to issue a Notice of Violation and a Notice of Proposed Imposition of Civil Penalties in the amount of Eight Thousard Dollars (58,000) to Diagnostic Isotopes, Incorporated.
This action was based on alleged items of noncompliance relating to the radiopharmaceutical operations of the licensee and involved extre:ity exposures of personnel, failure to report an expo ~sure to the NRC, inadequate surveys, inadequate instruction of personnel and failure to check generator eluates for molybdenum break-through.
The Notices were issued on October 15, IS79, and an NRC news release to that ei'ect was made on October 17, 1979.
The licensee responded to the Notices by letter dated November 5,1979.
After consideration of the licensee's response, the IE staff concluded that the licensee's response was not adequate and that additional information was necessary.
Also, in cur October 15, 1979 letter we referred to a potential item of ncaco:pliance pertaining to the obtaining of reports by Diagnostic Isotopes from its customers who receive technetium-99m eluate.
This matter has been clarified in discussions with the U.S. Food and Drug Administration and it has been deter:ined that the matter is an alleged item of noncompliance.
Consecuently, a Nctice of Violation has been issued to add an additional item of noncocpliance and the proposed penalty has been increased by 5500.
This is to inform the Commission that an additional Notice of Violation and an additional Notice of Proposed Imposition of Civil Penalty in the amount of Five Hundred Dollars (5500) has been issued today.
Also, additional information has been requested from the licensee to supplement their November 5 response to our October 15, 1979 Notice of Violation.
The licensee and the State of New Jersey are being inforned by telephone.
Since this matter has been the subject of a previous NRC news release, no additional release is planned. The Office of Public Affairs will respond to inquiries as received.
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The licensee has 20 days from the date of receipt of the Notices in which to respond.
Following NRC staff evaluation of the response, the civil penalties may be remitted, citigated or imposed by order.
e 1865 359 8002040
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EN-79-11A (Continued)
Page 2 of 2
Contact:
T. Brockett, IE x27246; G. Gower, IE x27246 Distribution:
Transmitted H St 3 '. O [
Chai rsan At>earne Coccissioner Bradford S. J. Chilk, SECY Comissioner Kennedy Coc=issioner Hendrie C. C. Kammerer, CA Comissioner Gilinsky ACRS (For Distribution)
Trans=itted: MNB3 P. Bldg V. Stello, IE L. V. Gossick, EIX)
H. R. Denton, NRR Region R% 3' O[
H. L. Ornstein, EDO R. C DeYoung, NRR J. J. Fouchard, PA R. J. Mattson, NRR Landow N. M. Haller, MPA D. Vassallo, NRR J. J. Cummings, OI A R. G. Ryan, OSP D. Eisenhut, NRR H. K. Shapar, ELD SS Bldg (MAIL)
W. J. Dircks, NMSS R. Minogue, SD S. Levine, RES PRELIMIMRY INFORMATION - NOT FOR PUBLIC DISCLOSURE UNTIL JANUARY 10, 1980 1865' 360
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