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Compliance References
Regulatory Procedures Manual 2008
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6-7 - EXHIBITS

6-7 - EXHIBITS

These exhibits include a number of models and examples.   They should be used only as guides and, with the possible exception of legal citations, should not automatically be used verbatim in any case.   Examples from recent cases may be found on ORA's intranet site.   The district compliance officer may request examples of inspection warrants, and other examples not available on ORA's intranet site, from DCMO, telephone (240) 632-6850. 

EXHIBITS

6-1  TELEPHONE SEIZURE RECOMMENDATION  (PDF icon, 10 KB)
6-2  SEIZURES - U.S MARSHAL LETTER  (PDF icon, 18 KB)
6-3  FORM OF DEFAULT DECREE OF CONDEMNATION  (PDF icon, 21 KB)
6-4  FORM OF CLAIM  (PDF icon, 19 KB)
6-5  FORM OF CONSENT DECREE OF CONDEMNATION  (PDF icon, 27 KB)
6-6  FORM OF BOND  (PDF icon, 20 KB)
6-7  NOTICE TO CLAIMANT  (PDF icon, 24 KB)
6-8  SECOND NOTICE  (PDF icon, 11 KB)
6-9  LETTER TO CANCEL BOND  (PDF icon, 10 KB)
6-10  PROCEDURES & MODELS FOR ISSUING PRESS RELEASES  (PDF icon, 48 KB)
6-11  INJUNCTIONS (MULTI-DISTRICT)  (PDF icon, 40 KB)
6-12  MODEL LETTER ACKNOWLEDGING COMPLIANCE  (PDF icon, 11 KB)
6-13  INTRODUCTORY LANGUAGE MODEL - DRUG GMP/ADULTERATION/MISBRANDING CASE  (PDF icon, 10 KB)
6-14  MODEL INTRODUCTORY LANGUAGE - FOOD ADULTERATION CASE  (PDF icon, 10 KB)
6-15  STANDARD PARAGRAPH REGARDING THE LAW OF INJUNCTIVE RELIEF IN CASES ARISING UNDER THE FEDERAL FOOD, DRUG, AND COSMETIC ACT  (PDF icon, 11 KB)
6-16  STANDARD DRUG GMP PARAGRAPH  (PDF icon, 11 KB)
6-17  STANDARD DIRTY WAREHOUSE PARAGRAPH  (PDF icon, 11 KB)
6-18  STANDARD MISBRANDING (343(A) AND 352(A)) PARAGRAPH  (PDF icon, 10 KB)
6-19  EXAMPLES OF COMPLAINT PROVISIONS  (PDF icon, 48 KB)
6-20  AFFIDAVIT/DECLARATION  (PDF icon, 26 KB)
6-21  EXAMPLES OF CONSENT DECREE PROVISIONS  (PDF icon, 45 KB)
6-22  MODEL LETTER BILLING CHARGES  (PDF icon, 11 KB)
6-23  PETITION FOR ORDER TO SHOW CAUSE  (PDF icon, 58 KB)
6-24  ORDER TO SHOW CAUSE  (PDF icon, 26 KB)
6-25  FORMAT FOR PROSECUTION SUMMARY AND RECOMMENDATION  (PDF icon, 25 KB)
6-26  MODEL PROSECUTION SUMMARY AND RECOMMENDATION MEMORANDUM  (PDF icon, 40 KB)
6-27  MODEL LETTER REQUEST FOR ARTICLES OF INCORPORATION  (PDF icon, 10 KB)
6-28  RULE 44 - PROOF OF OFFICIAL RECORD  (PDF icon, 12 KB)
6-29  RULE 6. THE GRAND JURY  (PDF icon, 40 KB)
6-30  EXAMPLE OF LETTER TO THE DEPARTMENT OF JUSTICE, RE: INJUNCTION AND CIVIL PENALTY  (PDF icon, 55 KB)
6-31  EXAMPLE OF COMPLAINT FOR INJUNCTION AND CIVIL PENALTY  (PDF icon, 162 KB)
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