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Specific Instructions for Completing Form FD2892 7
Examples Appendix I 15
Addresses of FDA District Offices Appendix III 43
12 other sections not shown
administrative inspection warrant adulterated amended aoxAap application Arnold & Porter authority CDRH cGMP Claimant classification name clinical investigation compliance components Cosmetic Act court criminal Decree defendants distribution distributor District document Drug Administration drug or device drug product employee ensure enter establishment evaluation expedited review FDA's FDCA Federal Food Food and Drug identify injunction intended interstate commerce investigational device investigational device exemption issued labeling manufacturer manufacturing practices marketed Medical Device misbranded monitoring Office owner/operator package packaging and labeling person postmarket surveillance premarket approval premarket notification procedures proposed 21 C.F.R. Prosecution pursuant records Refuse to Accept registration regulations request risk safety and effectiveness sample Secretary seizure action SMDA specific sponsor Stat submission submitted substantial equivalence telephone number United States Attorney violations ZIP CODE