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Category:CORRESPONDENCE-LETTERS
MONTHYEARML20137B1321997-03-12012 March 1997 Ack Receipt of Informing NRC of Steps Taken to Correct Violations Noted in Insp Rept 70-1342/96-01 ML20137B1521997-02-0707 February 1997 Responds to NRC 970107 NOV Re Violations Noted in Insp Rept 70-1342/96-01 on 961212.Corrective Actions:Physical Inventory Accounting for All Licensed Matl Was Completed on 970127 & Annual Rept for 1995/1996 Sent on 961226 ML20133E6351997-01-0707 January 1997 Discusses Insp 70-1342/96-01 on 961212 & Forwards Notice of Violation ML20248J4281992-11-20020 November 1992 Advises That Licensee Did Not Provide Valid Reason for Extension of Due Date of Invoice AMO2024-92,therefore Extension Cannot Be Granted ML20198E4541992-09-0303 September 1992 Requests Extension of 30-day Period Until Determination of Invoice Amount Can Be Made.Questions If Company Can Qualify for Small Entity Status ML20062A8161990-10-0303 October 1990 Discusses Telcon Inquiry 90-001 Re Activities Authorized by License SNM-1319.Renewal Application Received ML20155F5661987-10-31031 October 1987 Forwards Corrected Amend 21 to License SNM-1319.Amend Corrected,Per 870922 Request.Condition 13 Std for Stated Licenses.Memo Indicating That Not Amend But Corrected Copy W/Voiding Date of 871031 Encl ML20155F5941987-09-22022 September 1987 Requests Reissuance of Amend 21 to License SNM-1319 W/Stated Changes,Including Changing of Radiation Safety Officer from Fj Shipko to Jn Klingensmith & Indication That Ide No Longer in Effect ML20151D8601987-09-10010 September 1987 Forwards Amend 21 to License SNM-1319 ML20151D8841987-08-11011 August 1987 Forwards Amend 20 to License SNM-1319.Fee Paid ML20151D9531987-08-0606 August 1987 Requests Fee Re 870715 Application for Amend to License SNM-1319.Fee Required Prior to Issuance of Amend ML20215F1611986-10-0303 October 1986 Ack Receipt of Informing NRC of Steps Taken to Correct Violations Noted in Insp 70-1342/86-01 ML20215F1731986-09-18018 September 1986 Responds to NRC Re Violations Noted in Insp 70-1342/86-01.Corrective Actions:Vendor Will No Longer Ship nuclear-powered Pacemakers Internationally Under UN2911, Until Type B Package Obtained ML20206P3481986-08-21021 August 1986 Discusses Safety Insp 70-1342/86-01 on 860710 & Forwards Notice of Violation ML20215B3121986-08-21021 August 1986 Forwards Amend 20 to License SNM-1319 ML20215B3661986-07-24024 July 1986 Requests Fee for 860710 Application for Amend to License SNM-1319 ML20215B4001986-07-16016 July 1986 Forwards Fee for 860710 Application for Amend to License SNM-1319 ML20133P4451985-09-25025 September 1985 Forwards Amend 19,renewing License SNM-1319 ML20133P4521985-08-19019 August 1985 Responds to Request for Addl Info Re License SNM-1319.Model SAC-4 Scintillation Alpha Counter & Victoreen Model 488A Geiger Counter Will Be Used ML20133P4581985-08-0505 August 1985 Advises That Unless Response to 850529 Request for Addl Info Re 850502 Application for Renewal of License SNM-1319 Received within 30 Days,Application May Be Denied & License Terminated ML20133P4641985-05-29029 May 1985 Requests Addl Info Re 850502 Application for Renewal of License SNM-1319,including Info Re Survey Meters & Counting Equipment for Alpha & Neutrons & Outline of Annual Training Lecture Subjs ML20133P4681985-05-0202 May 1985 Forwards Application for Renewal of License SNM-1319 ML20133P4971985-03-0404 March 1985 Ack Receipt of Request for Complete Application for Renewal of License SNM-1319 ML20133P5131985-02-15015 February 1985 Requests Addl Info Re 840405 Application for Renewal of License SNM-1319,including Clarification of Reason for Not Sending Accountability Repts Since 830630,per License Condition 13.B ML20133P5281984-11-20020 November 1984 Forwards Human Implantation Protocol for Coratomic C-101-P Radioisotope Powered Cardiac Pacer. Protocol Approved by Nrc.Hosps Applying for Licenses to Implant Coratomic Model C-101-P Pacer Will Follow Protocol ML20133P5321984-10-0404 October 1984 Ack Receipt of Application for Renewal of License SNM-1319. License Will Not Expire Until Final NRC Action Taken ML20133P5431984-04-25025 April 1984 Forwards Fee for Application for Renewal of License SNM-1319 ML20133P5591984-04-20020 April 1984 Requests Fee for 840405 Application for Renewal of License SNM-1319.Fee Required Prior to Issuance of Amend 1997-03-12
[Table view] Category:OUTGOING CORRESPONDENCE
MONTHYEARML20137B1321997-03-12012 March 1997 Ack Receipt of Informing NRC of Steps Taken to Correct Violations Noted in Insp Rept 70-1342/96-01 ML20133E6351997-01-0707 January 1997 Discusses Insp 70-1342/96-01 on 961212 & Forwards Notice of Violation ML20248J4281992-11-20020 November 1992 Advises That Licensee Did Not Provide Valid Reason for Extension of Due Date of Invoice AMO2024-92,therefore Extension Cannot Be Granted ML20062A8161990-10-0303 October 1990 Discusses Telcon Inquiry 90-001 Re Activities Authorized by License SNM-1319.Renewal Application Received ML20155F5661987-10-31031 October 1987 Forwards Corrected Amend 21 to License SNM-1319.Amend Corrected,Per 870922 Request.Condition 13 Std for Stated Licenses.Memo Indicating That Not Amend But Corrected Copy W/Voiding Date of 871031 Encl ML20151D8601987-09-10010 September 1987 Forwards Amend 21 to License SNM-1319 ML20151D9531987-08-0606 August 1987 Requests Fee Re 870715 Application for Amend to License SNM-1319.Fee Required Prior to Issuance of Amend ML20215F1611986-10-0303 October 1986 Ack Receipt of Informing NRC of Steps Taken to Correct Violations Noted in Insp 70-1342/86-01 ML20206P3481986-08-21021 August 1986 Discusses Safety Insp 70-1342/86-01 on 860710 & Forwards Notice of Violation ML20215B3121986-08-21021 August 1986 Forwards Amend 20 to License SNM-1319 ML20215B3661986-07-24024 July 1986 Requests Fee for 860710 Application for Amend to License SNM-1319 ML20133P4451985-09-25025 September 1985 Forwards Amend 19,renewing License SNM-1319 ML20133P4581985-08-0505 August 1985 Advises That Unless Response to 850529 Request for Addl Info Re 850502 Application for Renewal of License SNM-1319 Received within 30 Days,Application May Be Denied & License Terminated ML20133P4641985-05-29029 May 1985 Requests Addl Info Re 850502 Application for Renewal of License SNM-1319,including Info Re Survey Meters & Counting Equipment for Alpha & Neutrons & Outline of Annual Training Lecture Subjs ML20133P5131985-02-15015 February 1985 Requests Addl Info Re 840405 Application for Renewal of License SNM-1319,including Clarification of Reason for Not Sending Accountability Repts Since 830630,per License Condition 13.B ML20133P5321984-10-0404 October 1984 Ack Receipt of Application for Renewal of License SNM-1319. License Will Not Expire Until Final NRC Action Taken ML20133P5591984-04-20020 April 1984 Requests Fee for 840405 Application for Renewal of License SNM-1319.Fee Required Prior to Issuance of Amend 1997-03-12
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JAN 71997 Docket No. 070-01342 License No. SNM-1319 Mr. David L. Purdy, President Biocontrol Technology, Inc.
300 Indian Springs Road indiana, Pennsylvania 15701
SUBJECT:
INSPECTION NO. 070-01342/96-001
Dear Mr. Purdy:
l On December 12,1996, John McFadden of this office conducted a safety inspection at 300 Indian Springs Road of activities authorized by the above-listed NRC license.
The inspection was an examination of your licensed activities as they relate to radiation safety and to compliance with the Commission's regulations and the license conditions. The inspection consisted of observations by the inspector, interviews with personnel, and a selective examination of representative records. The findings of the inspection were discussed with you, at the conclusion of the inspection.
Based on the results of this inspection, it appears that your activities were not conducted in full compliance with NRC requirements. A Notice of Violation is enclosed and categorizes each violation by severity levelin accordance with the
" General Statement of Policy and Procedure for NRC Enforcement Actions,"
(Enforcement Policy), NUREG 1600. You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your j response, in your response, you should document the specific actions taken and any '
additional actions you plan to prevent recurrence. With regard to item B. in the enclosed Notice of Violation, we received your Annual Report on December 30,1996.
While this corrects the specific violation, in your response to this letter, you still must I describe your actions to prepare and file this report on a timely basis. Your response i may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. After reviewing your response to this Notice, including your proposed corrective actions and the results of future j inspections, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC regulatory requirements.
Please use the enclosed self-addressed green envelope when you respond to this letter ;
to assist us in the timely processing of your response, in accordance with Section ;
2.790 of NRC's " Rules of Practice," Part 2, Title 10, Code of Federal Regulations, a copy of this letter and your reply will be placed in the Public Document Room (PDR).
To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. However, if you find it necessary to include such information, you should [ \-
OFFICIAL RECORD COPY RETUml ORIGINAL.TO ,
REGlQM032 - P' 9701130088 970107 PDR ADOCK 07001342 i C PDR ]
Mr. D.L. Purdy, President Biocontrol Technology, Inc.
clearly indicate the specific information that you desire not to be placed in the PDR, and provide the legal basis to support your request for withholding the information from the public. The responses directed by this letter and the accompanying Notice are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, PL 96-511.
Your cooperation with us is appreciated.
I Sincerely, i
ORIGINAL SIGNED BY:
John D. Kinneman, Chief Nuclear Materials Safety Branch 2 Division of Nuclear Materials Safety Docket No.: 070-01342 i
License No.: SNM-1319 l
l
Enclosure:
l Notice of Violation I
cc w/ enclosure: 1 Joseph N. Klingensmith, Radiation Safety Officer l
William O. Chishko, Manager-Ouality Assurance and Regulatory Compliance Commonwealth of Pennsylvania l
l I
i
! OFFICIAL RECORD COPY
Mr. D.L. Purdy, President Biocontrol Technology, Inc.
Distribution: w/enct PUBLIC Nuclear Safety Information Center (NSIC)
Region i Docket Room (w/ concurrences)
D. J. Holody, RI i
1 DOCUMENT NAME: R:\WPS\MLDL\LSNM1319 To r.c.iv. . copy of thi. jsocum.ni. indic.i. in in. box:, f = Copy w/oytach/enci "E" = Copy w/ attach /.nci "N" = No copy OFFICEf DNMS/K E DNfflS/Rl[ ,
N NAME/ JMpFEdden/jrm JKf % an DATER N/7/96 01'/1/97 01/ /97 01/ /97
- j i OFFICIAL RECORD COPY