FDA import refusal: Semaglutide (Anti-diabetic) (United Kingdom)
FDA refuses entry of injectable Semaglutide from the UK.
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Why FDA refused this
FDA refused this shipment at the U.S. border from ASIAN SUITS ONLINE LIMITED (Leicester), classified by FDA as Human Drugs.
Misbranding502(o), 801(a)(3); MISBRANDING
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Misbranding502(o), 801(a)(3); MISBRANDING
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Unapproved New Drug505(a), 801(a)(3); UNAPPROVED NEW DRUG
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Charge definitions via the FDA Refusal Charges Reference. Verify on the FDA firm profile ↗
FDA Import Refusal · FDA firm profile ↗FDA record · ASIAN SUITS ONLINE LIMITED · Leicester · drug product · refused as misbranding, unapproved new drug
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Monitoring, not legal advice.