Import Alert for Industry Bio & Licensed In-Vivo & In-Vitro Diag

Bio & Licensed In-Vivo & In-Vitro Diag

DWPE = Detain without physical examination
Import Alert Number Import Alert Type Publish Date Import Alert Name
57-06 DWPE 03/18/2011 "Detention Without Physical Examination of 714x Cancer/Aids Serum"
57-10 DWPE 01/14/2016 "Detention Without Physicla Examination of HTLV Blot 2.4 And HIV 1 Blot 1.3 From Genelabs Diagnostics Pte, Ltd, Singapore"
57-15 DWPE 01/14/2016 "Detention Without Physical Examination of Allergens And/Or Allergenic Products"
57-18 DWPE with Surveillance 01/20/2016 "Unlicensed Biologic Known As "THE ANTIDOTE""
57-20 DWPE 03/18/2011 "Imported Dura Mater Regulated Under Section 361 Of The Public Health Service Act (PHS Act)"
57-21 DWPE 03/11/2016 Detention without Physical Examination Of Whipworms and Hookworms Including Eggs and Larvae
66-14 DWPE with Surveillance 09/17/2014 "Reimportation of All Prescription Drugs for Human Use"
66-40 DWPE 11/14/2017 "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"
66-41 DWPE 11/14/2017 Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
89-08 DWPE 11/15/2017 ***"Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"***