Marlen Lemur Laboratories SA
FDA import alert and refusal historySan Jose, Costa RicaFEI 3040986446
Recorded by FDA as MARLEN LEMUR LABORATORIES SA
As of October 26, 2026, Marlen Lemur Laboratories SA is not on any FDA import alert in SupplierRadar's records; FDA refused 1 of its shipment line on December 5, 2025, 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
- Nicotinamide (niacinamide) (vitamin) · UNAPPROVED
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Marlen Lemur Laboratories SA
1 record, newest first. Each line links to the FDA page it came from.
2025
- Import refusalRefused, Nicotinamide (niacinamide) (vitamin)UNAPPROVEDEntry AEK-7960298-1Source
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 Marlen Lemur Laboratories SA
- Is Marlen Lemur Laboratories SA on an FDA import alert?
- No listing for Marlen Lemur Laboratories SA appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Costa Rica page.
- Has FDA refused shipments from Marlen Lemur Laboratories SA?
- Yes. FDA refused 1 shipment line from Marlen Lemur Laboratories SA on December 5, 2025. The most recent, on December 5, 2025, was nicotinamide (niacinamide) (vitamin), charged as UNAPPROVED (unapproved new drug).
- Why did FDA refuse Marlen Lemur Laboratories SA's shipments?
- The most frequent charge is UNAPPROVED (unapproved new drug, 1 line).
- What is Marlen Lemur Laboratories SA's FEI number?
- Marlen Lemur Laboratories SA's FDA Establishment Identifier (FEI) is 3040986446.
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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.