Bayer Mexico S.A. de C.V.
⚠️ High Risk
FEI: 1000556091 • Queretaro, Queretaro • MEXICO
FEI Number
1000556091
Location
Queretaro, Queretaro
Country
MEXICOAddress
BVld. Miguel de Cervantes Saavedra 259, Ampliacion Granada, Miguel Hidalgo, Queretaro, Queretaro, Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/3/2025 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/23/2024 | 66VMR99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 2/15/2024 | 60LDY99ANALGESIC, N.E.C. | Division of Southeast Imports (DSEI) | |
| 2/17/2023 | 61LCB42RIVAROXABAN | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/29/2022 | 60CBA57PSEUDOEPHEDRINE (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/29/2022 | 62GBA51NAPROXOL (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2022 | 63NDY04DEXPANTHENOL (CHOLINERGIC) | Division of Southeast Imports (DSEI) | |
| 6/17/2022 | 60LDY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/17/2021 | 61LDA42RIVAROXABAN | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/20/2021 | 62GBY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/11/2020 | 56OPY05ENROFLOXACIN (FLUOROQUINOLONE) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 6/1/2018 | 66VQK99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 1/12/2018 | 61WDY04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/3/2017 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 2/3/2017 | 62RDA11PRAZIQUANTEL (ANTI-SCHISTOSOMAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/11/2016 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/11/2016 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/7/2016 | 64GCY07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/29/2014 | 61WDY18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/13/2013 | 60NCY16TESTOSTERONE ENANTHATE (ANDROGEN) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/7/2013 | 64GDY13ESTRADIOL VALERATE (ESTROGEN) | Cincinnati District Office (CIN-DO) | |
| 12/9/2011 | 63BDY01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/7/2011 | 66VCE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/6/2011 | 65JDA39DROSPIRENONE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/20/2011 | 64GCY07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/6/2009 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/28/2008 | 62GBA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/10/2008 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/30/2008 | 61WAJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 3/6/2008 | 56BCL03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/11/2008 | 62GCA50NAPROXEN SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/24/2007 | 56BCE03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/3/2006 | 64UCA02ACARBOSE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/3/2006 | 61PCA99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/14/2005 | 61WCY04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/14/2005 | 64UCA02ACARBOSE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/14/2005 | 60LCA21DIPYRONE (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/13/2004 | 60LAB05ASPIRIN (ANALGESIC) | 473LABELING | New Orleans District Office (NOL-DO) |
| 6/24/2004 | 80MDSSENSOR, GLUCOSE, INVASIVE | Division of Southeast Imports (DSEI) | |
| 3/26/2003 | 61WCJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Chicago District Office (CHI-DO) | |
| 10/9/2002 | 56BYS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Bayer Mexico S.A. de C.V.'s FDA import refusal history?
Bayer Mexico S.A. de C.V. (FEI: 1000556091) has 41 FDA import refusal record(s) in our database, spanning from 10/9/2002 to 12/3/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Bayer Mexico S.A. de C.V.'s FEI number is 1000556091.
What types of violations has Bayer Mexico S.A. de C.V. received?
Bayer Mexico S.A. de C.V. has been cited for 9 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Bayer Mexico S.A. de C.V. come from?
All FDA import refusal data for Bayer Mexico S.A. de C.V. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.