ML19250E045
| ML19250E045 | |
| Person / Time | |
|---|---|
| Issue date: | 11/18/1980 |
| From: | Book H NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V) |
| To: | |
| Shared Package | |
| ML19250E034 | List: |
| References | |
| NUDOCS 8103190440 | |
| Download: ML19250E045 (2) | |
Text
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O APPEMDB A NOTICE OF VICLATION Pacific Radiophamacy, Ltd.
License 53-16991-OlMC As a result of the inspection conducted on October 20, 1980, and in accordance with the Interin Enforcement Policy 45 FR 66754 (October 7, 1980), the following violations were identified:
A.
License Condition 22. states that the licensee shall possen and 1se licensed material in accordance with statements, representations, c nd precedures contained in aoolication dated March 18, 1976; letter receive <1 September 9,1976, letters dated flovember 1,1976, Octoter 3, 1977, October 10, 1977, and July 12, 1979.
1.
Ittm 6, of the letter received September 9,1976, states that thyroid and urine counts will be performea montnly On the radiopharracist and all tecnnical personnei.
Contrary to License Conditbn 22., no thyroid or urine counts were performeo on the raciconarmacist between May o, 1980 and October 20, 19EO, the date of the inspection.
2.
Item 7, of the letter dated November 1,1976, states that only the products frea generators will Le corrpounded and/or ".ispensed.
Contrary to License Cor 'ition 22., Molybdenum 99/ Technetium 99m generators have been di. censed.
A technetium 99m generator was received from Pacific Radiopharmacy, Ltd. by Castle Memorial Hospite.1 cn October 20, 1920.
The generator contained 2.2 curies of activity on October '4,1980.
These ittms cor,stitute a Severity Level IV violati.:n (Supplement VII).
B.
License Conditicn 16. states *. hat the licensee may transport licensed material or deliver licensed material to a carrier for transport in accordance with tne provisions of Title 10 Code of Federal Regulatiens, Part 71, " Packaging of Padioactive t'aterial for Transpcrt and Transportation of Radioactive Material Under Certain Conditions."
10 CFR 71.5 states t. hat the licensee uust comply with the applicable requirements of the Departnent of Transportation ir. 49 CFR Parts 170-189.
49 CFR 173.295 (a) (1), "Racioactive material in normal forn." states that each shipper of a specification 7A packaging must maintain on file for at least one year after the latest shipment, a complete certification and supporting safety analysis demonstrating that the construction methods, packaging design, and materials of construction are in compliance with the specification.
8108190440 J
Contrary to License Cor.ditien 16., there was no certification o -
sucporting safety analysis available for inspection to demonstrate that two attach 6 cases rarked, "00T 7A TYPE A, Radioactive Materials",
which aro used to transpart radicactive raterials from the pharmacy to varicus hospitals, would meet the standards for Type A packages described in 49 CFR 173.29Mb).
This is a Severity Level IV violatian (Supplement V).
Pursuant to the provisiens of 10 CFR 2.201, Pacific Radiopharmacy, Ltd.
is hereby recuired to submit to this office within twenty-five days of the date of this h'otice, a written statement or explanation in reply, including:
(1) the corrective steps which have bcen taken and the results achieved; (2) corrective steos which will be taken to avoid further itens of ncncomnliance; and (3) the date when full coraliance will be acnieved.
Under the authority af Section ':82 of the Damic Energy Act of 1954, as atenced, this response shall be submitted under oath or affi'. ation.
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!? n RC Y '/
W u7 uatad v
.,/AH. E. Booki Chief, Fuel Facility and Materials Safety Branch
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