Instituto Samitas SA
FDA import alert and refusal historySantiago, ChileFEI 3013143980
Recorded by FDA as INSTITUTO SAMITAS SA
As of October 27, 2026, Instituto Samitas SA is not on any FDA import alert in SupplierRadar's records; FDA refused 1 of its shipment line on February 2, 2017, 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 Instituto Samitas SA
1 record, newest first. Each line links to the FDA page it came from.
2017
- Import refusalRefused, Folic acid (vitamin)UNAPPROVEDEntry 799-8951051-1Source
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 Instituto Samitas SA
- Is Instituto Samitas SA on an FDA import alert?
- No listing for Instituto Samitas SA appears in the FDA import alerts SupplierRadar checked on October 27, 2026. Country-wide alerts may still apply to its products; see the Chile page.
- Has FDA refused shipments from Instituto Samitas SA?
- Yes. FDA refused 1 shipment line from Instituto Samitas SA on February 2, 2017. The most recent, on February 2, 2017, was folic acid (vitamin), charged as UNAPPROVED (unapproved new drug).
- Why did FDA refuse Instituto Samitas SA's shipments?
- The most frequent charge is UNAPPROVED (unapproved new drug, 1 line).
- What is Instituto Samitas SA's FEI number?
- Instituto Samitas SA's FDA Establishment Identifier (FEI) is 3013143980.
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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.