Bayer Australia Ltd.
FDA import alert and refusal historyPymble, AustraliaFEI 1000436007
As of October 26, 2026, Bayer Australia Ltd. is not on any FDA import alert in SupplierRadar's records; FDA refused 2 of its shipment lines on August 3, 2020, 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 Bayer Australia Ltd.
2 records, newest first. Each line links to the FDA page it came from.
2020
- Import refusalSource
Refused, 2 lines in one entry: Folic acid (vitamin); Vitamin c (ascorbic acid)UNAPPROVEDEntry 799-8090829-5Show 2 linesHide lines
- Refused, Folic acid (vitamin)UNAPPROVEDEntry 799-8090829-5Source
- Refused, Vitamin c (ascorbic acid)UNAPPROVEDEntry 799-8090829-5Source
Refusal charges, in plain English
- UNAPPROVED2 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.
Questions about Bayer Australia Ltd.
- Is Bayer Australia Ltd. on an FDA import alert?
- No listing for Bayer Australia Ltd. appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Australia page.
- Has FDA refused shipments from Bayer Australia Ltd.?
- Yes. FDA refused 2 shipment lines from Bayer Australia Ltd. on August 3, 2020. The most recent, on August 3, 2020, was folic acid (vitamin), charged as UNAPPROVED (unapproved new drug).
- Why did FDA refuse Bayer Australia Ltd.'s shipments?
- The most frequent charge is UNAPPROVED (unapproved new drug, 2 lines).
- What is Bayer Australia Ltd.'s FEI number?
- Bayer Australia Ltd.'s FDA Establishment Identifier (FEI) is 1000436007.
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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.