ML20041D500
| ML20041D500 | |
| Person / Time | |
|---|---|
| Issue date: | 02/25/1982 |
| From: | Sreniawski D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20041D494 | List: |
| References | |
| NUDOCS 8203050360 | |
| Download: ML20041D500 (2) | |
Text
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4 Appendix t.
NOTICE OF VIOLATION Pharmatopes, Inc.
License No. 34-18309-01MD I
As a result of the inspection conducted on February 4,1982, and in accordance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the following violations were identified:
1.
License Condition No. 23 requires that licensed material be possessed and used in accordance with the statements, representations, and pro-cedures contained in certain referenced applications and letters.
i The referenced application dated October 5, 1978, states in Item No. 10 that survey instruments will be calibrated at least annually.
Contrary to the above, a Victoreen 493 G-M survey meter, serial number 1186, has been used daily to survey incoming packages and has not been calibrated from April 21, 1980, to the present.
This is a Severity Level V violation (Supplemer.t VII).
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2.
License Condition No. 10 states licensed material shall be used only at 4172 Crossgate Square, Blue Ash, Ohio.
Contrary to the above, on February 2, 1982, the invitro diagnostic testing laboratory authorized under License Condition No.6.E. was moved 1
to 5225 Creek Road, Blue Ash, Ohio, an unauthorized location.
This is a Severity Level V violation (Supplement VII).
3.
10 CFR 71.5(a) requires that no licensee shall transport any licensed material outside of the confines of his plant-~or other place of use unless-the licensee complies with the application regulations of the Department of Transportation in 49 CFR' Parts 170-189.
i 49 CFR 173.393(n)(9) states that prior to each shipment of any package, the shipper shall insure by examination or appropriate test that external radiation and contamination levels are within-the allowable limits as expressed in 49 CFR 173.397.
Contrary to the above, the appropriate tests were not made to insure that contamination levels were within the allowable limits on packages
.containing Mo-99/Tc-99m generators shipped to the manufacturer.
This is"a Severity Level V violation (S'upplement V).
B203050360 820226 NMS LIC30 34-18309-01MD PDR
e Appendix 4.
License Condition No. 22.E. (1) states each licensee shall main-tain for inspection by the Nuclear Regulatory Commission records of training for performance of molybdenum-99 breakthrough tests for each individual performing these tests.
Contra y to the above, records of training given to personnel performing molybdenum-99 breakthrough tests were not available for review on February 4, 1982.
This is a Severity Level VI violation (Supplement VII).
Pursuant to the provisions of 10 CFR 2.201, you are required to submit to this office within thirty days of the date of this Notice a written statement or explanation in reply, including for each item of noncompli-ance:
(1) corrective action taken and the results achieved; (2) corrective action to be taken to avoid further noncompliance; and (3) the date when full compliance will be achieved. Under the authority of Section 182 of the Atomic Energy Act of 1954, as amended, this response shall be submitted under oath or affirmation. Consideration may be given to extending your response time for good cause shown.
Dated b b
i D. J. h/ediawski, Chief
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A Ma rials Radiation Protection Lon 2 i
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