Laboratorios Demac Ltda
FDA import alert and refusal historyBogota, ColombiaFEI 3018036781
Recorded by FDA as LABORATORIOS DEMAC LTDA
As of October 26, 2026, Laboratorios Demac Ltda is not on any FDA import alert in SupplierRadar's records; FDA refused 4 of its shipment lines between July 10, 2026 and August 6, 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
- Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. · NOT LISTED
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Laboratorios Demac Ltda
4 records, newest first. Each line links to the FDA page it came from.
2026
- Import refusalSource
Refused, 2 lines in one entry: Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.NOT LISTEDNO ENGLISHFRNMFGREGUNAPPROVEDEntry AEK-0766811-3Show 2 linesHide lines
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.NOT LISTEDNO ENGLISHFRNMFGREGUNAPPROVEDEntry AEK-0766811-3Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.NOT LISTEDNO ENGLISHFRNMFGREGUNAPPROVEDEntry AEK-0766811-3Source
- Import refusalSource
Refused, 2 lines in one entry: Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.; Carnitine, vit/min/protein/unconventional dietary spec for human/animal, n.e.c.)UNAPPROVEDEntry AEK-0766814-7Show 2 linesHide lines
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry AEK-0766814-7Source
- Refused, Carnitine, vit/min/protein/unconventional dietary spec for human/animal, n.e.c.)UNAPPROVEDEntry AEK-0766814-7Source
Refusal charges, in plain English
- UNAPPROVED4 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.
- FRNMFGREG2 refused lines
FRNMFGREG
- 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.
- NOT LISTED2 refused lines
Product not listed with FDA
The product appeared to be a drug or device that is not included in the listing FDA requires under section 510(j) of the FD&C Act.
Questions about Laboratorios Demac Ltda
- Is Laboratorios Demac Ltda on an FDA import alert?
- No listing for Laboratorios Demac Ltda appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Colombia page.
- Has FDA refused shipments from Laboratorios Demac Ltda?
- Yes. FDA refused 4 shipment lines from Laboratorios Demac Ltda between July 10, 2026 and August 6, 2026. The most recent, on August 6, 2026, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as NOT LISTED (product not listed with fda).
- Why did FDA refuse Laboratorios Demac Ltda's shipments?
- The most frequent charges are UNAPPROVED (unapproved new drug, 4 lines) and FRNMFGREG (frnmfgreg, 2 lines).
- What is Laboratorios Demac Ltda's FEI number?
- Laboratorios Demac Ltda's FDA Establishment Identifier (FEI) is 3018036781.
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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.