Sanofi
FDA import alert and refusal historyBrussels, BelgiumFEI 3042278187
Recorded by FDA as SANOFI
As of October 26, 2026, Sanofi is not on any FDA import alert in SupplierRadar's records; FDA refused 1 of its shipment line on February 19, 2026, most often for unapproved new drug (UNAPPROVED).
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- Not listed
- Last import refusal
- Folic acid (vitamin) · UNAPPROVED
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Sanofi
1 record, newest first. Each line links to the FDA page it came from.
2026
- Import refusalRefused, Folic acid (vitamin)UNAPPROVEDEntry AEK-9318923-9Source
Refusal charges, in plain English
- UNAPPROVED1 refused line
Unapproved new drug
The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.
Questions about Sanofi
- Is Sanofi on an FDA import alert?
- No listing for Sanofi appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Belgium page.
- Has FDA refused shipments from Sanofi?
- Yes. FDA refused 1 shipment line from Sanofi on February 19, 2026. The most recent, on February 19, 2026, was folic acid (vitamin), charged as UNAPPROVED (unapproved new drug).
- Why did FDA refuse Sanofi's shipments?
- The most frequent charge is UNAPPROVED (unapproved new drug, 1 line).
- What is Sanofi's FEI number?
- Sanofi's FDA Establishment Identifier (FEI) is 3042278187.
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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.