FDA import refusal: Triamcinolone Acetonide (Glucocorticoid) (Guatemala)
FDA refuses Guatemala-sourced triamcinolone acetonide shipment.
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
Free weekly Brief
Get the changes that matter in plain English, every week — and be alerted when the rules move. No charge.
Members get the full “what to do” on every alert — in real time, for your states. Become a member →
The FDA record
- Firm
- LABORATORIO PIERSAN S.A.
- Origin
- Cdad, Guatemala
- Product
- Triamcinolone Acetonide (Glucocorticoid)
- FDA classification
- Human Drugs
- Refused
- Jul 24, 2026
- FDA district
- Division of Southeast Imports
- Firm FEI
- 3022672914
- FDA shipment ID
- 1FX-9736910-1/30002/1C
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).
Unapproved New Drug505(a), 801(a)(3); UNAPPROVED NEW DRUG
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
FDA charge codes on this record: 118 (Misbranding) · 75 (Unapproved New Drug). 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-9736910-1/30002/1C (or firm FEI 3022672914), refused Jul 24, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · LABORATORIO PIERSAN S.A. · Cdad · drug product · refused as misbranding, unapproved new drug
Related alerts
- FDA import refusal: Implant, Dermal, Collagen for Aesthetic Use (South Korea)
- 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.