Bruluagsa S.A. de C.V.
⚠️ High Risk
FEI: 3006073962 • Atlacomulco • MEXICO
FEI Number
3006073962
Location
Atlacomulco
Country
MEXICOAddress
Calle 18, Lote 10 Manzana 23, , Atlacomulco, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/29/2025 | 61PDB37INSULIN PURIFIED HUMAN SEMISYNTHETIC (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 2/12/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/18/2019 | 60SCA23METOCLOPRAMIDE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/8/2018 | 56BDY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2017 | 60SCA23METOCLOPRAMIDE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/10/2017 | 56ACY99PENICILLIN NATURAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/28/2016 | 56BCK03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/16/2016 | 60SDK23METOCLOPRAMIDE (ANTACID) | New Orleans District Office (NOL-DO) | |
| 11/9/2016 | 56CCK70CEFTRIAXONE SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/7/2011 | 66VCE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/11/2008 | 56CAB27CEPHALEXIN (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bruluagsa S.A. de C.V.'s FDA import refusal history?
Bruluagsa S.A. de C.V. (FEI: 3006073962) has 11 FDA import refusal record(s) in our database, spanning from 6/11/2008 to 10/29/2025.
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. Bruluagsa S.A. de C.V.'s FEI number is 3006073962.
What types of violations has Bruluagsa S.A. de C.V. received?
Bruluagsa S.A. de C.V. has been cited for 2 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 Bruluagsa S.A. de C.V. come from?
All FDA import refusal data for Bruluagsa 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.