FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (South Korea)
FDA refuses entry for collagen dermal implants from South Korea.
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Why FDA refused this
FDA refused this shipment at the U.S. border from SEORIN COMPANY CO LTD (Chuncheon), classified by FDA as General and Plastic Surgery Medical Devices.
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.
Charge definitions via the FDA Refusal Charges Reference. Verify on the FDA firm profile ↗
FDA Import Refusal · FDA firm profile ↗FDA record · SEORIN COMPANY CO LTD · Chuncheon · plastic-surgery device · refused as misbranding
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Monitoring, not legal advice.