Bayer S.A.
FDA import alert and refusal historyGuatemala, GuatemalaFEI 3003975165
As of October 26, 2026, Bayer S.A. is not on any FDA import alert in SupplierRadar's records; FDA refused 7 of its shipment lines between February 5, 2021 and July 17, 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 c (ascorbic acid) · UNAPPROVED
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Bayer S.A.
7 records, newest first. Each line links to the FDA page it came from.
2026
- Import refusalSource
Refused, 3 lines in one entry: Vitamin c (ascorbic acid); Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. and 1 moreUNAPPROVEDEntry AEK-0791122-4Show 3 linesHide lines
- Refused, Vitamin c (ascorbic acid)UNAPPROVEDEntry AEK-0791122-4Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry AEK-0791122-4Source
- Refused, Probiotics (vit/min/protein/unconventional dietary spec for human/animal, n.e.c.)UNAPPROVEDEntry AEK-0791122-4Source
- Import refusalRefused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.NO ENGLISHUNAPPROVEDEntry 799-4459510-0Source
2025
- Import refusalSource
Refused, 2 lines in one entry: Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry AEK-7377604-7Show 2 linesHide lines
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry AEK-7377604-7Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry AEK-7377604-7Source
2021
- Import refusalRefused, Vitamin c (ascorbic acid)NOT LISTEDUNAPPROVEDEntry 799-0646850-8Source
Refusal charges, in plain English
- UNAPPROVED7 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.
- NO ENGLISH1 refused line
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 LISTED1 refused line
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 Bayer S.A.
- Is Bayer S.A. on an FDA import alert?
- No listing for Bayer S.A. appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Guatemala page.
- Has FDA refused shipments from Bayer S.A.?
- Yes. FDA refused 7 shipment lines from Bayer S.A. between February 5, 2021 and July 17, 2026. The most recent, on July 17, 2026, was vitamin c (ascorbic acid), charged as UNAPPROVED (unapproved new drug).
- Why did FDA refuse Bayer S.A.'s shipments?
- The most frequent charges are UNAPPROVED (unapproved new drug, 7 lines) and NO ENGLISH (required label information not in english, 1 line).
- What is Bayer S.A.'s FEI number?
- Bayer S.A.'s FDA Establishment Identifier (FEI) is 3003975165.
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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.