PRODUCTOS MAVER S.A. D.E. C.V.
⚠️ High Risk
FEI: 3003238201 • JALISCO • MEXICO
FEI Number
3003238201
Location
JALISCO
Country
MEXICOAddress
PLANTA BETALACTAMICOS AV. OLEODUCTO, 2804 FRACC, INDUSTRIAL EL ALAMO, JALISCO, , 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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/20/2025 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/8/2024 | 61HAL99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/12/2023 | 56CCC72CEFUROXIME SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2022 | 80NKNSYRINGE, PISTON, REPROCESSED | 473LABELING | Division of Southeast Imports (DSEI) |
| 11/9/2022 | 62CCB10CLONIDINE HCL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/2/2022 | 62TCE02LANSOPRAZOLE (ANTI-SECRETORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/5/2021 | 62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2020 | 61GDY56SULFAMETHIZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/12/2020 | 61HCA99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/22/2020 | 60SCY10MAGALDRATE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2020 | 61ECA99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 64BDY25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/12/2020 | 56DDY49NEOMYCIN, N.E.C. (AMINOGLYCOSIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/10/2019 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/26/2016 | 56BDB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/5/2016 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/29/2016 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/16/2016 | 60LCA21DIPYRONE (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/2/2016 | 56YCA99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is PRODUCTOS MAVER S.A. D.E. C.V.'s FDA import refusal history?
PRODUCTOS MAVER S.A. D.E. C.V. (FEI: 3003238201) has 19 FDA import refusal record(s) in our database, spanning from 3/2/2016 to 5/20/2025.
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. PRODUCTOS MAVER S.A. D.E. C.V.'s FEI number is 3003238201.
What types of violations has PRODUCTOS MAVER S.A. D.E. C.V. received?
PRODUCTOS MAVER S.A. D.E. C.V. has been cited for 3 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 PRODUCTOS MAVER S.A. D.E. C.V. come from?
All FDA import refusal data for PRODUCTOS MAVER S.A. D.E. 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.