FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (France)
FDA refuses entry for dermal collagen implants from France.
What changed & why it matters
MedSpaRadar recorded an FDA import refusal at the federal level, dated August 14, 2026, in the Aesthetic Injectables category.
An import refusal marks a shipment the FDA stopped at the U.S. border as violative — the gray-market corridor a med spa must never source injectables from. Foreign, unapproved, or misbranded product refused at import is exactly what surfaces when a practice buys outside verified US-licensed 503A/503B or FDA-registered channels.
- Type
- FDA Import Refusal
- Jurisdiction
- Federal
- Category
- Aesthetic Injectables
- Recorded
- August 14, 2026
What this means for your practice — the step to take, the deadline to calendar or the supplier detail to check, where the change calls for one — is in the member "what to do" below. This page is the free record of what changed and why it matters.
What to do
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The FDA record
- Firm
- LABORTORIES FILLMED
- Origin
- Paris-L'Hopital, France
- Product
- Implant, Dermal, Collagen For Aesthetic Use
- FDA classification
- General and Plastic Surgery Medical Devices
- Refused
- Aug 14, 2026
- FDA district
- Division of Southeast Imports
- Firm FEI
- 3040646942
- FDA shipment ID
- AEK-0899189-4/50002/1
Why FDA refused it
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.
FDA charge codes on this record: 118 (Misbranding) · 237 (Adulteration) · 3280 (Misbranding). Definitions via the FDA Refusal Charges Reference.
Verify at FDA
FDA doesn’t publish a page per refusal. Open the FDA Import Refusals database and search by shipment ID AEK-0899189-4/50002/1 (or firm FEI 3040646942), refused Aug 14, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · LABORTORIES FILLMED · Paris-L'Hopital · plastic-surgery device · refused as misbranding, adulteration
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