Laboratorios Sante SA
FDA import alert and refusal historyGuatemala City, GuatemalaFEI 3027404177
Recorded by FDA as LABORATORIOS SANTE SA
As of October 25, 2026, Laboratorios Sante SA is not on any FDA import alert in SupplierRadar's records; FDA refused 2 of its shipment lines on May 29, 2026, most often for required label information not in english (NO ENGLISH).
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- Not listed
- Last import refusal
- Vitamin e (tocopherol) · NO ENGLISH
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Laboratorios Sante SA
2 records, newest first. Each line links to the FDA page it came from.
2026
- Import refusalSource
Refused, 2 lines in one entry: Vitamin e (tocopherol); Vitamin b1 (thiamine)NO ENGLISHUNAPPROVEDEntry 1FX-7544854-7Show 2 linesHide lines
- Refused, Vitamin e (tocopherol)NO ENGLISHUNAPPROVEDEntry 1FX-7544854-7Source
- Refused, Vitamin b1 (thiamine)NO ENGLISHUNAPPROVEDEntry 1FX-7544854-7Source
Refusal charges, in plain English
- NO ENGLISH2 refused lines
Required label information not in English
Information that must appear on the label appeared not to be given in English, or not to be repeated in every language used on the label.
- UNAPPROVED2 refused lines
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 Laboratorios Sante SA
- Is Laboratorios Sante SA on an FDA import alert?
- No listing for Laboratorios Sante SA appears in the FDA import alerts SupplierRadar checked on October 25, 2026. Country-wide alerts may still apply to its products; see the Guatemala page.
- Has FDA refused shipments from Laboratorios Sante SA?
- Yes. FDA refused 2 shipment lines from Laboratorios Sante SA on May 29, 2026. The most recent, on May 29, 2026, was vitamin e (tocopherol), charged as NO ENGLISH (required label information not in english).
- Why did FDA refuse Laboratorios Sante SA's shipments?
- The most frequent charges are NO ENGLISH (required label information not in english, 2 lines) and UNAPPROVED (unapproved new drug, 2 lines).
- What is Laboratorios Sante SA's FEI number?
- Laboratorios Sante SA's FDA Establishment Identifier (FEI) is 3027404177.
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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.