FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (Italy)
FDA refuses dermal collagen implant shipment from Italy.
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
- LICOFARMA SRL
- Origin
- Galatina, Italy
- 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
- 3014223152
- FDA shipment ID
- 1FX-7859895-0/10002/1
Why FDA refused it
Misbranding502(a),(f)(1), 801(a)(3); MISBRANDING
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
FDA charge codes on this record: 84 (Misbranding) · 9999973 (no public definition) · 9999974 (no public definition) · 9999976 (no public definition). 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 1FX-7859895-0/10002/1 (or firm FEI 3014223152), refused Aug 14, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · LICOFARMA SRL · Galatina · plastic-surgery device · refused as misbranding
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