FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (Canada)
FDA refuses collagen implant shipment from Canada; check your suppliers.
What changed & why it matters
MedSpaRadar recorded an FDA import refusal at the federal level, dated August 12, 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 12, 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.
Firm inspection: Voluntary Action Indicated
This firm’s most recent FDA inspection was classified Voluntary Action Indicated (VAI) — objectionable conditions FDA expects the firm to correct.
Source: FDA Data Dashboard inspection classifications (most recent, by firm FEI).
What to do
Free weekly Brief
Get the changes that matter in plain English, every week — and be alerted when the rules move. No charge.
Members get a specific “what to do” wherever a change calls for one — in one daily email, for your states. See one unlocked → · Pricing →
The FDA record
- Firm
- Prollenium Medical Technologies Inc.
- Origin
- Aurora, Canada
- Product
- Implant, Dermal, Collagen For Aesthetic Use
- FDA classification
- General and Plastic Surgery Medical Devices
- Refused
- Aug 12, 2026
- FDA district
- Division of Southeast Imports
- Firm FEI
- 3004423487
- FDA shipment ID
- 1FX-9633400-7/30002/1
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.
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: 118 (Misbranding) · 237 (Adulteration) · 3280 (Misbranding) · 84 (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 1FX-9633400-7/30002/1 (or firm FEI 3004423487), refused Aug 12, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · Prollenium Medical Technologies Inc. · Aurora · plastic-surgery device · refused as misbranding, adulteration
Related alerts
- FDA import refusal: Botox (onabotulinumtoxinA) (South Korea)
- FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (South Korea)
- FDA import refusal: Botox (onabotulinumtoxinA) (South Korea)
- FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (South Korea)
- FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (Vietnam)
- FDA import refusal: Acid, Hyaluronic, Intraarticular (Sweden)
MedSpaRadar is regulatory monitoring and reference: it summarizes public laws, regulations and agency actions and links each to its source. It is not legal, medical, or compliance advice, and using it creates no attorney-client relationship. A summary can lag its source or leave out detail, and monitoring itself can be interrupted — so an absence of alerts means nothing reached you, not that nothing happened. Read the cited source, check its effective date, and confirm any change to your operations or clinical practice with qualified health-law counsel and your medical director.