ML25345A468
| ML25345A468 | |
| Person / Time | |
|---|---|
| Site: | 07100121 |
| Issue date: | 12/12/2025 |
| From: | Gerond George NRC/NMSS/DFM/IOB |
| To: | Ransohoff W Neutron Products |
| References | |
| IR 2025201 | |
| Download: ML25345A468 (0) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 William L. Ransohoff, President Neutron Products Inc.
22301 Mt. Ephraim Dickerson, MD 20842
SUBJECT:
NEUTRON PRODUCTS INC. - U.S. NUCLEAR REGULATORY COMMISSION INSPECTION REPORT NO. 071000121/2025201
Dear William L. Ransohoff:
On September 25, 2025, the U.S. Nuclear Regulatory Commission (NRC) completed an inspection at Neutron Products Inc. in Ranson, West Virginia. The inspectors discussed the results of this inspection with you and other members of your staff. The results of this inspection are documented in the enclosed report.
One violation of more than minor significance is documented in this report. This involved a violation of NRC requirements. We are treating this violation as a Severity Level IV non-cited violation consistent with section 2.3.2 of the Enforcement Policy.
If you contest this violation, you should provide a response within 30 days of the date of this inspection report, with the basis for your denial, to the NRC, ATTN: Document Control Desk, Washington DC 205550001, with copies to: (1) the Director, Office of Nuclear Material Safety and Safeguards; and (2) the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 205550001.
December 12, 2025
W. Ransohoff 2
In accordance with Title 10 of the Code of Federal Regulations Section 2.390, Public inspections, exemptions, requests for withholding, a copy of this letter will be available electronically for public inspection in the NRC Public Document Room (PDR) or from the Publicly Available Records component of the NRCs Agencywide Documents Access and Management System (ADAMS). ADAMS is accessible from the NRC website at http://www.nrc.gov/reading-rm/adams.html. The PDR is open by appointment. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. eastern time (ET), Monday through Friday, except Federal holidays.
Sincerely, Gerond George, Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards Docket No. 07100121
Enclosure:
Inspection Report No. 07100121/2025201 Signed by George, Gerond on 12/12/25
ML25345A468 OFFICE NMSS/DFM NMSS/DFM NMSS/DFM NAME ADjapari SFigueroa GGeorge DATE 12/11/2025 12/12/2025 12/12/2025
Enclosure U.S. NUCLEAR REGULATORY COMMISSION Office of Nuclear Material Safety and Safeguards Division of Fuel Management Inspection Report Docket:
07100121 Report:
07100121/2025201 Enterprise Identifier:
I-2025-201-0040 Certificate Holder:
Neutron Products Inc.
Locations:
Ranson, WV Inspection Dates:
September 23 - 25, 2025 Inspection Team:
Azmi Djapari, Transportation and Storage Safety Inspector, Lead Eucherius Rosario, Transportation and Storage Safety Inspector Andres Rowe, Transportation and Storage Safety Inspector Approved by:
Gerond George, Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards
2
SUMMARY
Neutron Products Inc.
NRC Inspection Report 07100121/2025201 This routine inspection performed at Neutron Products Inc.s (NPIs) facilities in Ranson, West Virginia and Dickerson, Maryland from September 23 - September 25, 2025, evaluated the ongoing activities related to the transportation of radioactive material in the U.S. Nuclear Regulatory Commission (NRC)-approved transportation packagings. The purpose of the inspection was to verify and assess the adequacy of NPIs transportation related activities to determine if they were performed in accordance with the requirements of Title 10 of the Code of Federal Regulations (10 CFR) Part 71, Packaging and Transportation of Radioactive Material, the certificates of compliance (CoCs) and safety analysis reports (SARs) for transportation packagings that NPI holds the CoC approval, and the NRC-approved quality assurance program (QAP).
List of Findings and Violations Failure to Follow Procedures Regarding Control of Measuring and Test Equipment and Nonconformances Report Section Severity Level IV NCV 07100121/2025201-01 Closed 86001 The inspectors identified a Severity Level IV (SLIV) non-cited violation (NCV) of 10 CFR 71.111, Instructions, Procedures, and Drawings, for the CoC holders failure to follow the requirements of procedure R-5155 Revision 2, Control of Inspection Measuring and Test Equipment - Materials Transportation. Specifically, the CoC holder failed to either initiate measures to validate previous inspection and test results back to the last calibration, or failed to consider a nonconformance when torque wrench (2502LDIN)/ 0 -250 in/lb, 101507206, and dial caliper, GS258608, were found to be out of calibration.
Additional Tracking Items There are no additional tracking items.
3 INSPECTION SCOPES The inspection was conducted using the appropriate portions of Inspection Procedure (IP) 86001, Design, Fabrication, Testing, and Maintenance of Transportation Packaging. Currently approved IPs are located on the public website at http://www.nrc.gov/reading-rm/doc-collections/insp-manual/inspection-procedure/index.html. The inspectors reviewed selected procedures and records, observed activities, and interviewed personnel to assess CoC holder performance and compliance with Commission rules and regulations, license conditions, site procedures, and standards. The inspection was declared complete when the objectives of the IP were met, consistent with Inspection Manual Chapter (IMC) 2690, Inspection Program for Storage of Spent Reactor Fuel and Reactor-Related Greater-Than-Class C Waste at Independent Spent Fuel Storage Installations and for 10 CFR Part 71 Transportation Packagings.
IP 86001 - Design, Fabrication, Testing, and Maintenance of Transportation Packaging The inspectors performed a routine assessment of the effectiveness of the CoC holders adherence to applicable regulatory requirements; NRC-approved QAP; 10 CFR Part 21; design control; maintenance and testing; procurement control; nonconformance and corrective action programs; personnel training and certifications; and audits program.
Quality Assurance Program: The inspectors conducted a review of the quality assurance program and organization that described the functions, authorities, and responsibilities.
The inspectors assessed the effectiveness of CoC holders quality activities related to transportation packagings to determine that activities are being conducted in accordance with the CoC, as well as the NRC-approved QAP, and that implementing procedures are in place and effective. The inspectors discussed portions of these documents with selected personnel to assess adequate control and implementation of activities subject to 10 CFR Part 71.
10 CFR Part 21: The inspectors assessed the effectiveness of the provisions in place for reporting defects which could cause a substantial safety hazard, as required by 10 CFR Part 21, Reporting of Defects and Noncompliance. The inspectors reviewed CoC holders implementing quality procedures to verify whether provisions were in place for reporting defects that could cause a substantial safety hazard from the nonconformances and quality issues identified. The inspectors reviewed selected records and interviewed personnel to verify effective implementation of the nonconformance control program in accordance with their NRC-approved QAP and the requirements of 10 CFR Part 21. The inspectors also reviewed postings within the facility to determine compliance with 10 CFR 21.6, "Posting Requirements."
Design Control: The inspectors assessed the effectiveness of the CoC holders processes for controlling design documentation for adequate implementation by reviewing selected documents and interviewing personnel. The inspectors reviewed selected quality classification evaluation for important to safety (ITS) components associated with CoC No. 71-0121 for the Type B NPI-20WC-6 MKII packages. The inspectors reviewed the configuration control and design review process and associated documentation. The inspectors noted that the CoC holder did not perform any design changes or modifications for 10 CFR Part 71 CoC.
Maintenance and Testing: The inspectors reviewed selected drawings, procedures, and records and observed demonstrated maintenance and testing activities to verify that they
4 met the design commitments and requirements in the SAR and CoC. The inspectors confirmed that activities were performed in accordance with approved methods, procedures, and specifications. The inspectors conducted a walkdown of transportation packagings used and stored onsite, including the NPI-20WC-6 MKII, to assess material condition and quality controls. Documentation reviewed included certifications, inspection reports, completed checklists, and special routings for non-routine maintenance.
Procurement Control: The inspectors reviewed selected drawings, records, and conducted interviews to verify procurement specifications for materials, equipment, and services received met applicable design requirements. The implementation of the CoC holders process for receiving and dedicating commercial-grade items/services as basic components and/or for procuring ITS components was assessed with the review of selected samples.
Nonconformance and Corrective Action Programs: The inspectors evaluated the effectiveness of CoC holders nonconformance and corrective action program by reviewing selected records and interviewing personnel. The inspectors focused on how CoC holders addressed nonconforming materials, parts, and components, and whether corrective actions for identified deficiencies were technically sound and completed in a timely manner.
Personnel Training and Certifications: The inspectors reviewed selected records and procedures, interviewed personnel, and observed activities to verify that individuals performing activities affecting quality were properly trained and qualified. They confirmed that management and quality assurance (QA) staff were cognizant of their responsibilities and provided appropriate oversight. Selected records and procedures included those related to the training, qualification, and certification of personnel involved in quality-related activities, including qualification and training records for selected lead auditors and personnel responsible for performing maintenance on the NPI-20WC-6 MKII package.
Audit Programs: The inspectors verified the CoC holder's established audit program, including the scheduling and performance of audits of each of the 18 elements of this QAP and activities affecting the safety-related aspects of the packaging. A sample of audits from 2020-2025 was reviewed to assess compliance with regulatory and QAP requirements. The inspectors confirmed that when audit program issues were identified, they were evaluated and addressed through the corrective action program to ensure appropriate follow-up and prevention of recurrence.
5 INSPECTION RESULTS Failure to Follow Procedures Regarding Control of Measuring and Test Equipment and Nonconformances Report Section Severity Level IV NCV 07100121/2025201-01 Closed 86001 The inspectors identified a Severity Level IV (SLIV) NCV of 10 CFR 71.111, Instructions, Procedures, and Drawings, for the CoC holders failure to follow the requirements of procedure R-5155 Revision 2, Control of Inspection Measuring and Test Equipment -
Materials Transportation. Specifically, the CoC holder failed to either initiate measures to validate previous inspection and test results back to the last calibration, or failed to consider a nonconformance when torque wrench (2502LDIN)/ 0 -250 in/lb, 101507206, and dial caliper, GS258608, were found to be out of calibration.
==
Description:==
Measuring and test equipment procedure R-5155 Revision 2, "Control of Inspection Measuring and Test Equipment - Materials Transportation," section 6.5, states, "When an instrument is found to be out of calibration, the Quality Assurance Manager Radioactive Transportation (QAMRT) shall initiate measures to validate previous inspection and test results back to the last calibration. When previous results cannot be validated or are shown to be out of specification, this shall be considered a nonconformance and handled in accordance with procedure R-5507. The nonconformance process is documented in procedure R-5507, Revision 5, Control of Nonconforming Packaging Radioactive Material Transportation (Division 3).
On April 27, 2022, the certificate holder referred torque wrench 1015107206 for calibration testing due to becoming inoperable. Torque wrench, 1015107206, failed this calibration test.
On May 3, 2022, the certificate holder documented the identification of the failed torque wrench and generated memo, "Inactivate Equipment - torque wrench (1015107206)." As per the memo's justification, the torque wrench was used incorrectly by manufacturing therefore, resulting in the equipment becoming inoperable. The equipment was immediately marked out of service and a calibration test was performed. The equipment failed calibration and was removed from use. The inspectors noted there were no records to validate previous inspection and test results back from the last calibration for torque wrench, 1015107206.
Also, on August 12, 2024, the certificate holder performed a routine calibration on dial caliper, GS258608, which subsequently failed. On August 25, 2024, the certificate holder documented the decommissioning of dial caliper, GS258608, in an associated memo. As per the memos justification, the caliper was decommissioned due to failing calibration upon the calipers scheduled calibration date. The decommissioning memo stated, in part, The impact of the failed calibration was found to be minimal risk, as the calipers were inoperable upon receipt. The inspectors noted there were no records to validate previous inspection and test results back from the last calibration for dial caliper, GS258608.
The inspectors requested documentation of measures to validate previous test results or associated nonconformance reports if the previous test results could not be validated. The certificate holder could not provide records of validation or a generated nonconformance report for either the torque wrench 1015107206 or the dial caliper GS258608. The request revealed NPI failed to follow procedure, R-5155, due to the lack of measures to validate previous inspection and test results back to the last calibration or the lack an associated nonconformance report for torque wrench 1015107206 and dial caliper GS258608.
6 Corrective Actions: The CoC holder entered the issues into their corrective action program.
The CoC holder revised the memo associated with the torque wrench and dial caliper to provide the required justification to satisfy the requirements in R-5155.
Corrective Action References: 1-NCR-2025-RT-007, Retrospective Evaluations for Inoperable MT&E (Torque Wrench and Calipers)
Analysis:
The inspectors evaluated the violation using the traditional enforcement process in section 2.2.2 of the NRC Enforcement Policy. The inspectors determined the violation was of more than minor safety significance in accordance with inspection guidance provided in Appendix E, Minor Examples of Vendor and QA Implementation Findings, Example 10e of IMC 0617 Vendor and Quality Assurance Implementation Inspection Reports, because the examiner did not record the indication which would have required an evaluation. The examination was deemed acceptable and was not re-performed. The inspectors characterized the violation as an SL IV violation in accordance with the NRC Enforcement Policy and Manual.
Enforcement:
Violation: 10 CFR 71.111, "Instructions, Procedures, and Drawings," requires, in part, that a certificate holder for a CoC shall prescribe activities affecting quality by documented instructions, procedures, or drawings of a type appropriate to the circumstances and shall require that these instructions, procedures, and drawings be followed. The certificate holder established R-5155 Revision 2, insert title, as the implementing procedure for controlling measuring and test equipment, an activity affecting quality.
Procedure R-5155 Revision 2, Step 6.5, states, When an instrument is found to be out of calibration, the Quality Assurance Manager Radioactive Transportation (QAMRT) shall initiate measures to validate previous inspection and test results back to the last calibration. When previous results cannot be validated or are shown to be out of specification, this shall be considered a nonconformance and handled in accordance with procedure R-5507.
Contrary to the above, on May 3, 2022, the certificate holder failed to follow Step 6.5 of procedure R-5155 Revision 2. Specifically, the certificate holder failed to initiate measures to validate previous inspection and test results back to the last calibration or considered a nonconformance and handled in accordance with procedure R-5507 for torque wrench, 1015107206. Additionally, contrary to the above, on August 25, 2024, the certificate holder failed to follow Step 6.5 of procedure R-5155 Revision 2. Specifically, the certificate holder failed to initiate measures to validate previous inspection and test results back to the last calibration or considered a nonconformance and handled in accordance with procedure R-5507 for dial caliper, GS258608.
Enforcement Action: This violation is being treated as a NCV, consistent with section 2.3.2 of the NRC Enforcement Policy.
7 EXIT MEETINGS AND DEBRIEFS The inspectors verified that no proprietary information was retained or documented in this report.
On September 25, 2025, the inspectors presented the inspection results to William L.
Ransohoff, President, and other members of the licensee staff.
8 DOCUMENTS REVIEWED Inspection Procedure Type Designation Description or Title Revision or Date 0618110544 Torque Wrench 07/10/2025 1015107206 Torque Wrench - Certificate of Calibration 10/27/2021 1015107206 Memo - Inactivate Equipment -
Torque Wrench (1015107206 )
03/05/2022 2285773 Thread Plug - E/M Working -
Certificate of Calibration 07/10/2024 2362941 Thread Plug - E/M Setting -
Certificate of Calibration 04/08/2024 2369489 Thread Ring - E/M - Certificate of Calibration 04/08/2024 2609413 Thread Ring - E/M - Certificate of Calibration 07/10/2024 44197-A Durometer - Certificate of Calibration 11/17/2023 665490 (98500931)
Length Standard - Certificate of Calibration 11/18/2023 Calibration Records 672 Thread Plug - E/M Working -
Certificate of Calibration 03/27/2025 CA-2019-RT-001 Generated from 71-0121/2019-201 Drawing Related 12/18/2019 CA-2019-RT-002 Gen from 71-0121/2019-201 QA Related 12/18/2019 CA-2019-RT-003 Gen from 71-0121/2019-201 QA Related 12/19/2019 CA-2019-RT-004 Gen from 71-0121/2019-201 QA Related 12/19/2019 CA-2025-RT-001 CA Identifying CAs and NCRs Associated With IR 71-0121/2019-2101 08/09/2025 CA-2025-RT-002 Training records lost 08/09/2025 CA-2025-RT-003 Meeting/Discussion summary not done 08/09/2025 CA-2025-RT-004 Ultrasonic testing training, gen from 2025 internal audit 08/09/2025 CA-2025-RT-005 CA Identifying 5 Open NCRs from 2018 and 2019 08/09/2025 CA-2025-RT-006 CA Identifying 4 Open CAs With Respect to IR 71-0121/2019-201 08/09/2025 CA-2025-RT-007 2025 Internal Audit Finding # 7 08/09/2025 NCR-2019-RT-001 Tungsten Material (Use As Is) 04/17/2019 86001 Corrective Action Documents NCR-2019-Approval Date Mismatch on 12/18/2019
9 Inspection Procedure Type Designation Description or Title Revision or Date RT-006 QAMRT (71-0121/2019-201)
NCR-2019-RT-007 Control Copy Number NCR (71-0121/2019-201) 12/18/2019 NCR-2019-RT-008 Gen from 71-0121/2019-201 CA checklist 12/18/2019 NCR-2019-RT-009 Gen from 71-0121/2019-201 QA Related 12/18/2019 NCR-2019-RT-010 CA Practice Not in QAP (71-0121/2019-201) 12/18/2019 NCR-2019-RT-011 Gen from 71-0121/2019-201 generated CA-2019-RT-002 12/18/2019 NCR-2021-RT-001 MOS 14 Damage (repair) 05/03/2021 NCR-2025-RT-001 Torque Wrench Used Past Calibration Due Date 01/23/2025 NCR-2025-RT-005 Visual Inspection Form Change (Include WPJ/MOS) 09/24/2025 NCR-2025-RT-006 Procedure Change for Internal Audits - R-5510 Ver 3 09/24/2025 Corrective Action Documents Resulting from Inspection NCR-2025-RT-007 Retrospective Evaluations for Inoperable MT&E (Torque Wrench and Calipers) 09/25/2025 Supplier Qualification ID No.
031031 Calibration Services associated with gauges, calipers, and torque wrenches.
10/06/2024 Supplier Qualification ID No.
031093 Tungsten Shield Plugs and Tungsten Materials.
10/05/24 Miscellaneous Supplier Qualification ID No.
031101 Laboratory Testing and Calibration Services 02/24/25 Procedure C-9011 Documenting and Recording Nonconformances Rev 0 QAP Quality Assurance Program for the Transportation of Radioactive Materials Rev 11 R-2019-G Maintenance and Storage Procedure Rev 2 R-2031 Repair of Shipping Package Components Rev 6 R-5507 Control of Nonconforming Packaging Radioactive Material Transportation (Division 3)
Rev 5 Procedures R-5508 Purchasing - Purchasing Material Transportation (RMT)
Rev 7
10 Inspection Procedure Type Designation Description or Title Revision or Date R-5509 Training and Proficiency Assessments - Radioactive Materials Transportation Rev 3 R-5510 Internal Audit - RMT Rev 3 2025 - IA Neutron Products Inc. 2025 Internal Audit Report 08/07/2025 Self-Assessments KQS Audit Report #2023 Neutron Products Inc. 2023 Internal Audit 04/18/2023 32202 Cubhaven - Visual Inspection Checklist 08/08/2022 33191 General Atomics - Visual Inspection Checklist 01/12/2022 33207 Leon Levy - Visual Inspection Checklist 11/15/2022 33241 Visual Inspection Checklist for TC-9 OP-11 09/24/2024 33243 General Dynamics - Visual Inspection Checklist 12/09/2024 33244 UPenn - Visual Inspection Checklist 03/13/2025 3964 JLS to Lockhead - Visual Inspection Checklist 01/27/2023 Work Orders MOS-14 Repair package for MOS 14 11/30/2021