ML20003E534
| ML20003E534 | |
| Person / Time | |
|---|---|
| Issue date: | 03/30/1981 |
| From: | Stello V NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | Hebner M PHARMATOPES, INC. |
| Shared Package | |
| ML20003E535 | List: |
| References | |
| EA-81-003, EA-81-3, NUDOCS 8104060060 | |
| Download: ML20003E534 (2) | |
Text
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UNITED STATES j 3 e..( [ }
NUCLEAR REGULATORY COMMISSION p, b'M
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WASHINGTON, D. C. 20555 o,,gv.....f MAR 3 01981
\\v r License No. 08-18108-01MD Q-EA 81-03 j'
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O )D Pharmatopes, Inr.orporated f"%
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, ATTN:
Mr. Mark Hebner M
8 4h g 3 President M
t 25721 Coolidge Highway Oak Park, Michigan 48237 p
Gentlemen:
This responds to your letter dated January 6, 1981, which was in response to the Notice of Violation and Notice of Proposed Imposition of Civil Penalties sent to you with our letter dated December 15, 1980.
Af ter careful co'nsideration of your letter and for the reasons given in the enclosed Order and Appendix, we have determined that the items of noncom-pliance did occur as set out in the Notice of Violation.
No adequate reasons have been stated as to why the penalties for these items, except for item D, should not be imposed as proposed in the Notice of Proposed Imposition of Civil Penalties.
Accordingly, we hereby serve the enclosed Order imposing civil penalties in the cumulative amount of Seven Thousand Fifty Dollars.
Furthermore, additional information is needed regarding your corrective actions for several of the items of noncompliance identified in the December 15, 1980 Notice of Violation.
Your " intra-company compliance inspections" or audits are an important part of your corrective actions. Therefore, specify the qualifications of the personnel who will conduct these audits and the frequency with which they will be conducted.
In response to items C.2 and C.3, you failed to provide sufficient information with respect to the specific surveys which will be taken to ensure compliance with 10 CFR 20.103 and 10 CFR 20.106.
In response to item D, while we are not imposing a civil penalty for this
! tem, we remain concerned about the adequacy of your training program.
Please provide additienal detailed information with respect to the scope and frequency of your training program for pharmacists, drivers, and clerical personnel.
You should also specify the qualifications of the personnel who will conduct the training.
In response to item E, you failed to provide corrective actions to ensure that each package is in an unimpaired condition and has the required security seal prior to saipment.
In response to item F.6,:you failed to describe steps you are taking to ensure a sensitivity of 100 disintegrations per minute for your method for performing wipe _ tests.
Please provide a written statement containing the above information within ten (10) days of receipt of this letter.
We plan to continue unannounced inspections of your licensed activities.
The results of these inspections, including your implementation of the corrective actions described in your letter and in response to this letter, will be considered in determining whether any further enforcement action,~such as modification, suspension or revocation of your license is appropriate.
CERTIFIED MAIL i
RETURN RECEIPT REQUESTED l
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Pharmatopes, Incorporated i In accordance with Section 2.790 of the NRC's " Rules of Practice," Part 2, Title 10, Code of Federal Regulations, a copy of this letter and the enclosures will be placed in the NRC's Public Document Room.
Sincerely, i
ictor Stello, Jr.
Director Office of Inspection and Enforcement
Enclosure:
-Order Imposing Civil Monetary Penalties With Appendix A, Evaluations and Conclusions cc w/ enclosure:
A. Mckusick, Manager Pharmatopes, Inc.
1 4545 43rd Street l
Washington, D.C.
20016 i
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