FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (Colombia)

What to do

Why FDA refused this

FDA refused this shipment at the U.S. border from GALDERMA DE COLOMBIA SA (Cl), classified by FDA as General and Plastic Surgery Medical Devices.

• 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).

• Adulteration501(f)(1)(B), 801(a)(3); ADULTERATION

  The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

• 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.

• Misbranding502(o), 801(a)(3); MISBRANDING

  It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

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