Biopure EU Ltd.
FDA import alert and refusal historyGuntramsdorf, AustriaFEI 3012634653
Recorded by FDA as BIOPURE EU LTD.
As of October 26, 2026, Biopure EU Ltd. is not on any FDA import alert in SupplierRadar's records; FDA refused 4 of its shipment lines on December 2, 2020, most often for not identified as a dietary supplement (DIETARYLBL).
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. · DIRECTIONS
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Biopure EU Ltd.
4 records, newest first. Each line links to the FDA page it came from.
2020
- Import refusalSource
Refused, 4 lines in one entry: Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.DIRECTIONSLIST INGREDIETARYLBLLACKS FIRMEntry 471-0206322-0Show 4 linesHide lines
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.DIRECTIONSLIST INGREDIETARYLBLLACKS FIRMLACKS N/CPLANT PARTNCONTACTNUTRIT LBLUNAPPROVEDEntry 471-0206322-0Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.DIRECTIONSLIST INGREDIETARYLBLLACKS FIRMLACKS N/CPLANT PARTNCONTACTNUTRIT LBLUNAPPROVEDEntry 471-0206322-0Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.DIRECTIONSLIST INGREDIETARYLBLLACKS FIRMLACKS N/CPLANT PARTNCONTACTNUTRIT LBLUNAPPROVEDEntry 471-0206322-0Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.DIRECTIONSLIST INGREDIETARYLBLLACKS FIRMLACKS N/CPLANT PARTNCONTACTNUTRIT LBLUNAPPROVEDEntry 471-0206322-0Source
Refusal charges, in plain English
- DIETARYLBL4 refused lines
Not identified as a dietary supplement
The label appeared not to identify the product with the term "dietary supplement" (which may be modified with the name of an ingredient).
- DIRECTIONS4 refused lines
DIRECTIONS
- LACKS FIRM4 refused lines
Manufacturer name and address missing
The packaged product's label appeared not to show the name and place of business of the manufacturer, packer, or distributor.
- LACKS N/C4 refused lines
Net quantity statement missing
The packaged food appeared not to carry an accurate statement of the quantity of contents, such as net weight, measure, or count, on its label.
- LIST INGRE4 refused lines
Ingredients not listed
The product is made from two or more ingredients and the label appeared not to list the common or usual name of each one (or, for a juice beverage, the percentage of juice).
- NCONTACT4 refused lines
No U.S. adverse event contact on supplement label
The dietary supplement label appeared not to show a U.S. address or phone number through which a serious adverse event can be reported.
- NUTRIT LBL4 refused lines
Nutrition information missing from label
The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.
- PLANT PART4 refused lines
PLANT PART
Questions about Biopure EU Ltd.
- Is Biopure EU Ltd. on an FDA import alert?
- No listing for Biopure EU Ltd. appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Austria page.
- Has FDA refused shipments from Biopure EU Ltd.?
- Yes. FDA refused 4 shipment lines from Biopure EU Ltd. on December 2, 2020. The most recent, on December 2, 2020, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as DIRECTIONS (directions).
- Why did FDA refuse Biopure EU Ltd.'s shipments?
- The most frequent charges are DIETARYLBL (not identified as a dietary supplement, 4 lines) and DIRECTIONS (directions, 4 lines).
- What is Biopure EU Ltd.'s FEI number?
- Biopure EU Ltd.'s FDA Establishment Identifier (FEI) is 3012634653.
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