ML18221A542
| ML18221A542 | |
| Person / Time | |
|---|---|
| Site: | 03038114 |
| Issue date: | 07/12/2018 |
| From: | Gordon C Z Division of Nuclear Materials Safety I |
| To: | Rodriguez N Lantheus Medical Imaging |
| References | |
| IR 2018001 | |
| Download: ML18221A542 (1) | |
Text
NRC FORM 591M PART 1 (07-2012)'
U.S. NUCLEAR REGULATORY COMMISSION 10 CFR2.201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION
- 1. LICENSEE/LOCATION INSPECTED:
Lantheus Medical Imaging 150 Federico Costa, Suite 1 San Juan, Puerto Rico 00918-1303 REPORT NUMBER(S) 2018-001 2. NRG/REGIONAL OFFICE U.S. Nuclear Regulatory Commission Region I, 2100 Renaissance Blvd, Suite 100 King of Prussia, Pennsylvania 19406-2713
- 3. DOCKET NUMBER(S) 030-38114 1 4. LICENSE NUMBER(S) 52-25361-02 1 5. DATE(S) OF INSPECTION February 14-July 12, 2018. LICENSEE:
The inspection was an examination of the activities conducted under your license as they relate to radiation safety and to compliance with the Nuclear Regulatory Commission (NRC) rules and regulations and the conditions of your license. The Inspection consisted of selective examinations of procedures and representative records, interviews with personnel, and observations by the inspector.
The Inspection findings are as follows: 1. Based on the inspection findings, no violations were identified.
- 2. Previous violation(s) closed. 3. The violation(s), specifically described to you by the inspector as non-cited violations, are not being cited because they were identified, non-repetitive, and corrective action was or is being taken, and the remaining criteria in the NRC Enforcement Policy, to exercise discretion, were satisfied.
Non-cited violation(s) were discussed involving the following requirement(s) and corrective actlon(s):
- 4. During this Inspection, certain of your activities, as described below and/or attached, were in violation of NRC requirements and are being cited in accordance Y!ith the NRC Enforcement Policy. This fonn Is a NOTICE OF VIOLATION, which may be subject to posting In accordance with 1 O CFR 19.11. (Vlolatlons and Corrective Actions) 10 CFR 20.2103(a) requires that each licensee shall maintain records showing the results of surveys and calibrations required by 10 CFR 20.1501. The licensee shall retain these records for three years after the record is made. Contrary to the above, as of February 14, 2018, the licensee did not maintain records of the results of surveys performed after December 31, 2017, and these surveys were required by 10 CFR 20.1501. This is a Severity Level IV violation (Enforcement Policy Section 6.3 d.) Immediate corrective actions were taken by the licensee by providing additional instruction to laboratory workers to ensure required surveys are performed and implemented revision to waste handling practices In areas where contaminated waste is generated.
This is item is closed. Statement of Corrective Actions I hereby state that, within 30 days, the actions described by me to the Inspector will be taken to correct the violations Identified.
This statement of corrective actions Is made in accordance with the requirements of 10 CFR 2.201 (corrective steps already taken, corrective steps which will be taken, date when full compliance will be achieved).
I understand that no further written response to NRC will be required, unless specifically requested.
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~~=~:~.d~~u;~erations --;2.-:-c:.,_k I o/7 // 8 NRCINSPECTOR BRANCH CHIEF \,* I *NRC FORM 591M PART 1 (07-2012) (RI Rev. 09/12/2013)
G:\WBL Documents\WBL Inspection Records\R52-25361-02.2018-001.591M-Part1.doc SUNSI Review Completed By: IRA/ CGordon 0 Public 0 Non-Sensitive This document becomes an NRC Official Agency Record once it is signed by the Branch Chief