IR 07100121/2025201
| 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
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 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:
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
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.
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 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.
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.
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.
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.
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
285773
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
2
Thread Plug - E/M Working -
Certificate of Calibration
03/27/2025
CA-2019-RT-
001
Generated from 71-0121/2019-
201 Drawing Related
2/18/2019
CA-2019-RT-
2
Gen from 71-0121/2019-201 QA
Related
2/18/2019
CA-2019-RT-
003
Gen from 71-0121/2019-201 QA
Related
2/19/2019
CA-2019-RT-
004
Gen from 71-0121/2019-201 QA
Related
2/19/2019
CA-2025-RT-
001
CA Identifying CAs and NCRs
Associated With IR 71-
21/2019-2101
08/09/2025
CA-2025-RT-
2
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
25 Internal Audit Finding # 7
08/09/2025
NCR-2019-
Tungsten Material (Use As Is)
04/17/2019
86001
Corrective
Action
Documents
NCR-2019-
Approval Date Mismatch on
2/18/2019
Inspection
Procedure
Type
Designation
Description or Title
Revision or
Date
QAMRT (71-0121/2019-201)
NCR-2019-
Control Copy Number NCR (71-
21/2019-201)
2/18/2019
NCR-2019-
Gen from 71-0121/2019-201 CA
checklist
2/18/2019
NCR-2019-
Gen from 71-0121/2019-201 QA
Related
2/18/2019
NCR-2019-
CA Practice Not in QAP (71-
21/2019-201)
2/18/2019
NCR-2019-
Gen from 71-0121/2019-201
generated CA-2019-RT-002
2/18/2019
NCR-2021-
MOS 14 Damage (repair)
05/03/2021
NCR-2025-
Torque Wrench Used Past
Calibration Due Date
01/23/2025
NCR-2025-
Visual Inspection Form Change
(Include WPJ/MOS)
09/24/2025
NCR-2025-
Procedure Change for Internal
Audits - R-5510 Ver 3
09/24/2025
Corrective
Action
Documents
Resulting from
Inspection
NCR-2025-
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
2/24/25
Procedure C-
9011
Documenting and Recording
Nonconformances
Rev 0
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
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
25 - 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
202
Cubhaven - Visual Inspection
Checklist
08/08/2022
33191
General Atomics - Visual
Inspection Checklist
01/12/2022
207
Leon Levy - Visual Inspection
Checklist
11/15/2022
241
Visual Inspection Checklist for
TC-9 OP-11
09/24/2024
243
General Dynamics - Visual
Inspection Checklist
2/09/2024
244
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