Bayer de Guatemala S.A.
FDA import alert and refusal historyZona 3, GuatemalaFEI 3041554508
Recorded by FDA as BAYER DE GUATEMALA S.A.
As of October 26, 2026, Bayer de Guatemala S.A. is not on any FDA import alert in SupplierRadar's records; FDA refused 4 of its shipment lines on July 13, 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 b12 (cyanocobalamin) · UNAPPROVED
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Bayer de Guatemala S.A.
4 records, newest first. Each line links to the FDA page it came from.
2026
- Import refusalSource
Refused, 4 lines in one entry: Vitamin b12 (cyanocobalamin); Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry AEK-0568510-1Show 4 linesHide lines
- Refused, Vitamin b12 (cyanocobalamin)UNAPPROVEDEntry AEK-0568510-1Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry AEK-0568510-1Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry AEK-0568510-1Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry AEK-0568510-1Source
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.
Questions about Bayer de Guatemala S.A.
- Is Bayer de Guatemala S.A. on an FDA import alert?
- No listing for Bayer de Guatemala 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 de Guatemala S.A.?
- Yes. FDA refused 4 shipment lines from Bayer de Guatemala S.A. on July 13, 2026. The most recent, on July 13, 2026, was vitamin b12 (cyanocobalamin), charged as UNAPPROVED (unapproved new drug).
- Why did FDA refuse Bayer de Guatemala S.A.'s shipments?
- The most frequent charge is UNAPPROVED (unapproved new drug, 4 lines).
- What is Bayer de Guatemala S.A.'s FEI number?
- Bayer de Guatemala S.A.'s FDA Establishment Identifier (FEI) is 3041554508.
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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.