FDA import refusal: Botox (onabotulinumtoxinA) (Vietnam)
FDA refuses entry of OnabotulinumtoxinA from Vietnam; verify 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, naming ONABOTULINUMTOXINA.
An import refusal marks a shipment of ONABOTULINUMTOXINA 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
- Substance
- ONABOTULINUMTOXINA
- 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
- TRAN THI THU HIEN
- Origin
- Ha Noi City, Vietnam
- Product
- Onabotulinumtoxina
- FDA classification
- Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Refused
- Jul 24, 2026
- FDA district
- Division of Southeast Imports
- Firm FEI
- 3042887718
- FDA shipment ID
- SCS-7477813-2/10002/1
Why FDA refused it
FDA does not publish plain-language definitions for this shipment’s charge codes (a drugs and biologic refusal) — the firm, product, and origin above carry the meaning.
FDA charge codes on this record: 9999979 (no public definition) · 9999982 (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 SCS-7477813-2/10002/1 (or firm FEI 3042887718), refused Jul 24, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · TRAN THI THU HIEN · Ha Noi City · drug product · refused entry by FDA
Related alerts
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- FDA import refusal: Lidocaine (Belgium)
- FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (Brazil)
- FDA import refusal: Botox (onabotulinumtoxinA) (Ireland)
- FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (Vietnam)
- FDA import refusal: Acid, Hyaluronic, Intraarticular (Sweden)
Monitoring, not legal advice.