FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (Austria)
FDA refuses entry of collagen implants from Austria; verify your suppliers.
What changed & why it matters
Med Spa Radar recorded an FDA import refusal at the federal level, dated July 24, 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
- July 24, 2026
What this means for your specific practice — the exact step to take, the deadline to calendar, or the supplier detail to check — 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
- CROMA-PHARMA GMBH
- Origin
- Leobendorf, Austria
- Product
- Implant, Dermal, Collagen For Aesthetic Use
- FDA classification
- General and Plastic Surgery Medical Devices
- Refused
- Jul 24, 2026
- FDA district
- Division of Southeast Imports
- Firm FEI
- 3002806738
- FDA shipment ID
- 1FX-1405215-3/10002/1
Why FDA refused it
FDA does not publish plain-language definitions for this shipment’s charge codes (a device refusal) — the firm, product, and origin above carry the meaning.
FDA charge codes on this record: 9999973 (no public definition) · 9999974 (no public definition) · 9999976 (no public definition).
Verify at FDA
FDA doesn’t publish a page per refusal. Open the FDA Import Refusals database and search by shipment ID 1FX-1405215-3/10002/1 (or firm FEI 3002806738), refused Jul 24, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · CROMA-PHARMA GMBH · Leobendorf · plastic-surgery device · refused entry by FDA
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Monitoring, not legal advice.