FDA import refusal: Hyaluronidase (France)

What changed & why it matters

MedSpaRadar recorded an FDA import refusal at the federal level, dated August 19, 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 19, 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.

What to do

The FDA record

Firm

IBSA Pharma SAS

Origin

Antibes, France

Product

Hyaluronidase

FDA classification

Human and Animal Therapeutic Biologic and Biosimilar Drugs

Refused

Aug 19, 2026

FDA district

Division of Southeast Imports

Firm FEI

3024048417

FDA shipment ID

1FX-3387421-4/10002/1

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).

• 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(c), 801(a)(3); MISBRANDING

  Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

• Misbranding502(c); 801(a)(3) ;MISBRANDING

  Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

• 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) · 3280 (Misbranding) · 336 (Misbranding) · 472 (Misbranding) · 75 (Unapproved New Drug) · 9999978 (no public definition) · 9999979 (no public definition) · 9999982 (no public definition). Definitions via the FDA Refusal Charges Reference.