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Import Alert for Industry Bio & Licensed In-Vivo & In-Vitro Diag
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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
04/18/2023
"DETENTION WITHOUT PHYSICAL EXAMINATION OF UNLICENSED IMMUNE GLOBULIN INTRAVENOUS (HUMAN)"
57-15
DWPE
08/27/2024
"Detention Without Physical Examination of Unlicensed Allergenic Products"
57-20
DWPE
10/04/2023
"Imported Dura Mater Regulated Under Section 361 Of The Public Health Service Act (PHS Act)"
57-21
DWPE
09/01/2023
Detention without Physical Examination Of Whipworms and Hookworms Including Eggs and Larvae
66-40
DWPE
09/10/2024
"Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"
66-41
DWPE
09/18/2024
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
66-66
DWPE
06/06/2024
"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"
89-08
DWPE
09/16/2024
"Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
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