Biopax Ltd
FDA import alert and refusal historyTaichung, TaiwanFEI 3022503028
Recorded by FDA as BIOPAX LTD
As of October 25, 2026, Biopax Ltd is not on any FDA import alert in SupplierRadar's records; FDA refused 3 of its shipment lines on January 18, 2024, 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
- Ashwagandha (herbal & botanicals, not teas) · NO PROCESS
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Biopax Ltd
3 records, newest first. Each line links to the FDA page it came from.
2024
- Import refusalSource
Refused, 3 lines in one entry: Ashwagandha (herbal & botanicals, not teas); Vitamin, n.e.c.NO PROCESSDIETARYLBLALLERGENUNAPPROVEDEntry U83-2351864-6Show 3 linesHide lines
- Refused, Ashwagandha (herbal & botanicals, not teas)NO PROCESSEntry U83-2351864-6Source
- Refused, Vitamin, n.e.c.DIETARYLBLEntry U83-2351864-6Source
- Refused, Vitamin, n.e.c.DIETARYLBLALLERGENUNAPPROVEDEntry U83-2351864-6Source
Refusal charges, in plain English
- DIETARYLBL2 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).
- ALLERGEN1 refused line
Major food allergen not declared
The label appeared not to declare all major food allergens present in the product, as section 403(w) of the FD&C Act requires.
- NO PROCESS1 refused line
No scheduled process filed
The manufacturer appeared not to have filed a scheduled process with FDA, which 21 CFR Part 108 requires for low-acid canned and acidified foods, so the product is treated as made under insanitary conditions.
- 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 Biopax Ltd
- Is Biopax Ltd on an FDA import alert?
- No listing for Biopax Ltd appears in the FDA import alerts SupplierRadar checked on October 25, 2026. Country-wide alerts may still apply to its products; see the Taiwan page.
- Has FDA refused shipments from Biopax Ltd?
- Yes. FDA refused 3 shipment lines from Biopax Ltd on January 18, 2024. The most recent, on January 18, 2024, was ashwagandha (herbal & botanicals, not teas), charged as NO PROCESS (no scheduled process filed).
- Why did FDA refuse Biopax Ltd's shipments?
- The most frequent charges are DIETARYLBL (not identified as a dietary supplement, 2 lines) and ALLERGEN (major food allergen not declared, 1 line).
- What is Biopax Ltd's FEI number?
- Biopax Ltd's FDA Establishment Identifier (FEI) is 3022503028.
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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.