FDA import refusal: Botox (onabotulinumtoxinA) (Ireland)
FDA refuses entry of onabotulinumtoxinA from Ireland.
What changed & why it matters
Med Spa Radar recorded an FDA import refusal at the federal level, dated July 31, 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 31, 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.
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
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The FDA record
- Firm
- Allergan Pharmaceuticals Ireland
- Origin
- Westport, Ireland
- Product
- Onabotulinumtoxina
- FDA classification
- Human and Animal Therapeutic Biologic and Biosimilar Drugs
- Refused
- Jul 31, 2026
- FDA district
- Division of Southeast Imports
- Firm FEI
- 3002806285
- FDA shipment ID
- SCS-0349383-8/40002/3
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) · 9999983 (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-0349383-8/40002/3 (or firm FEI 3002806285), refused Jul 31, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · Allergan Pharmaceuticals Ireland · Westport · drug product · refused entry by FDA
Related alerts
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- 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.