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
57-11 DWPE 10/30/2024 "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNLICENSED IMMUNE GLOBULIN INTRAVENOUS (HUMAN)"
57-15 DWPE 10/30/2024 "Detention Without Physical Examination of Unlicensed Allergenic Products"
57-20 DWPE 10/30/2024 "Imported Dura Mater Regulated Under Section 361 Of The Public Health Service Act (PHS Act)"
57-21 DWPE 09/12/2025 Detention without Physical Examination Of Whipworms and Hookworms Including Eggs and Larvae
57-22 DWPE 05/29/2026 “Detention Without Physical Examination of Unlicensed Biological Products Promoted in the U.S.”
66-40 DWPE 06/22/2026 "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"
66-41 DWPE 06/24/2026 Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
66-66 DWPE 10/22/2024 "APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122"
66-79 DWPE 06/22/2026 "Detention Without Physical Examination of Drugs From Foreign Establishments Refusing FDA Inspection"
89-08 DWPE 06/24/2026 "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"