BRULUART SA
⚠️ High Risk
FEI: 3012416785 • Tultitan • 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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/24/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/10/2025 | 65RDY99REPLENISHER N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/30/2024 | 62GDA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/11/2024 | 62GCB49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/5/2024 | 66TCY01ALLOPURINOL (XANTHINE OXIDASE INHIBITOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2024 | 60LDY99ANALGESIC, N.E.C. | Division of Southeast Imports (DSEI) | |
| 2/15/2024 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2023 | 61GDE57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/27/2023 | 66ECY99IODINE SUPPLEMENT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/15/2022 | 62GDP18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/12/2022 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/12/2022 | 61GDA57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/26/2022 | 60QDY07LIDOCAINE | Division of Southeast Imports (DSEI) | |
| 6/13/2022 | 61XCA08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2021 | 62GDA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/28/2021 | 62CCB99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/23/2020 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2020 | 54ADB04VITAMIN B6 (PYRIDOXINE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/31/2019 | 62GDL99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/31/2019 | 62GDL99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/6/2018 | 62GCA90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/31/2017 | 56YCC99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/28/2017 | 62GDY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/28/2017 | 62GDY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/10/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/10/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/9/2017 | 62GDA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/4/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/8/2016 | 64ODY99MONOCLONAL ANTIBODIES, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/20/2015 | 62GDK18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Cincinnati District Office (CIN-DO) | |
| 3/20/2015 | 60QBK07LIDOCAINE | Cincinnati District Office (CIN-DO) | |
| 3/12/2013 | 60XBY02METOPROLOL (ANTI-ADRENERGIC) | Florida District Office (FLA-DO) | |
| 3/12/2013 | 62OAY29ENALAPRILATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/7/2011 | 66VCE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/11/2008 | 62GAB50NAPROXEN SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/11/2008 | 62GAB59PIROXICAM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is BRULUART SA's FDA import refusal history?
BRULUART SA (FEI: 3012416785) has 36 FDA import refusal record(s) in our database, spanning from 6/11/2008 to 9/24/2025.
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. BRULUART SA's FEI number is 3012416785.
What types of violations has BRULUART SA received?
BRULUART SA has been cited for 4 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 BRULUART SA come from?
All FDA import refusal data for BRULUART SA 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.