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Radioactive Materials Branch
Inspection Guidance

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Manufacturing & Distribution

This category encompasses a wide range of activities.  It covers licensee who manufacture and/or distribute radioactive materials or devices containing radioactive materials to other licensees.  The device and/or radioactive materials may be distributed to either General Licensees or Specific Licensees.  The manufacturing & distribution category includes distribution of prepared radiopharmaceuticals (nuclear pharmacies).


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Inspection Frequency* (see notes below) HOME OFFICE:   Every five (5) years
                         (Pharmacies every two (2) years)
FIELD USE:  No set frequency (see notes below)
Duration of the inspection 4 hours to 2 days depending on the scope and extent of licensed activities.
Scope of the Inspection Variable.  Scope is determined by taking into account the COMPLIANCE HISTORY as well as issues identified during the current inspection.  The scope and extent of the inspection will be discussed at the entrance meeting, but MAY CHANGE depending on findings during the course of the inspection.
Information that licensee needs to make available at the time of inspection

[Note:   The information presented here is NOT an all-inclusive list.  It is being presented here to give the licensee general guidance on records most frequently audited during an inspection]

Organizational chart, Annual Radiation Protection Program Reviews conducted since last inspection, radiation safety procedures, personnel dosimetry records (if applicable), leak tests, physical inventory of sources, records of receipt, transfer (including license verification for recipients) and disposal, QA/QC manual and records of tests, copies of the Radioactive Materials License and all subsequent amendments, and other pertinent records which demonstrate compliance with the applicable sections of 10A NCAC 15.
Performance-based component Inspectors will observe and interview radiation workers and the RSO to determine how certain tasks in the manufacturing and distribution of the product are accomplished, observe packaging and transportation of the product, observe surveys, etc.
Who needs to be available for entrance and exit meetings? Preferably, the highest ranking official needs to attend both the entrance and exit meetings.  The agency recognizes that this is not always possible, but the expectation is that an authorized representative of that individual be present at the meetings.
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*:  Inspection frequency may vary depending upon the licensee's COMPLIANCE HISTORY.  Repeat violations and violation involving health and safety issues may warrant an increased frequency of inspection.

:   Field use (e.g. transportation, waste pickup) can be inspected AT ANY TIME.   The licensee may have more than one field inspection per "normal inspection cycle" (e.g. 2 or 3 field inspections in a one year time frame).

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Last Modified: 28 October 2016
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