ML22362A135
| ML22362A135 | |
| Person / Time | |
|---|---|
| Site: | 99902107 |
| Issue date: | 12/29/2022 |
| From: | Kerri Kavanagh NRC/NRR/DRO/IQVB |
| To: | Vishwanathan H Fluke Biomedical Company |
| References | |
| Download: ML22362A135 (2) | |
Text
Mr. Harish Vishwanathan Quality Assurance Manager Fluke Biomedical Company 28775 Aurora Road Solon, Ohio 44139
SUBJECT:
VENDOR INSPECTION OF FLUKE BIOMEDICAL COMPANYS QUALITY ASSURANCE PROGRAM AND TITLE 10 OF THE CODE OF FEDERAL REGULATIONS PART 21 PROGRAM IMPLEMENTATION
Dear Mr. Vishwanathan:
This letter documents the U.S. Nuclear Regulatory Commission (NRC) staffs plan to perform an inspection of Fluke Biomedical Companys Appendix B, Quality Assurance Program Criteria for nuclear Power Plants and Fuel Reprocessing Plants, to Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities, and 10 CFR Part 21, Reporting of Defects and Noncompliance, programs as they pertain to activities conducted at your facility related to the manufacturing of radiation monitoring equipment, replacement parts and calibration and repair services for NRCs regulated facilities.
As discussed through e-mail on December 20, 2022, the NRC inspection team plans to arrive at your facility on Monday, February 6, 2023, and will conduct an inspection through Friday, February 10, 2023. Subsequent to the inspection, a report will be issued and transmitted to you via letter. The lead inspector for this effort is Mr. Dong Park, and you may contact him at (301) 415-0001 or via electronic mail at Dong.Park@nrc.gov.
This inspection activity has been assigned the following docket number: 99902107. Please reference this number on any correspondence relating to this inspection activity sent to the NRC.
Sincerely, Kerri A. Kavanagh, Chief Quality Assurance and Vendor Inspection Branch Division of Reactor Oversight Office of Nuclear Reactor Regulation Docket No.: 99902107 December 29, 2022 Signed by Kavanagh, Kerri on 12/29/22
ML22362A135 NRR-106 OFFICE NRR/DRO/IQVB NRR/DRO/IQVB NAME DPark KKavanagh DATE 12/29/2022 12/29/2022