Productos Medix, S.A. de C.V.
🚨 Critical Risk
FEI: 3009932533 • Mexico Df, DF • MEXICO
FEI Number
3009932533
Location
Mexico Df, DF
Country
MEXICOAddress
Calzada del Hueso No. 39, Col. Ex Ejidos de Santa Ursula Coapa, Mexico Df, DF, Mexico
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe 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 |
|---|---|---|---|
| 12/9/2025 | 66JCA05THYROID (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/9/2025 | 66JCA05THYROID (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/3/2025 | 65CCY99NUTRIENT/TONIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/22/2023 | 61XDA08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | Division of Southeast Imports (DSEI) | |
| 7/20/2023 | 54ADE15VITAMIN D2 (CALCIFEROL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/26/2023 | 61NCY69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/23/2022 | 61WCY18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/20/2022 | 54AGA99VITAMIN, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/22/2022 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2022 | 60RCE16PHENTERMINE (ANOREXIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2021 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/11/2021 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2021 | 54ABA15VITAMIN D2 (CALCIFEROL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 61EDY08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/24/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/5/2019 | 60RCH16PHENTERMINE (ANOREXIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/26/2018 | 66VBH99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2018 | 61ECA08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/9/2018 | 60CDH57PSEUDOEPHEDRINE (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/25/2017 | 66VCF99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/31/2017 | 64LCA03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/26/2017 | 60CCE57PSEUDOEPHEDRINE (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/31/2017 | 64LCA03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/21/2017 | 66FDY99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2017 | 66FDY99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2017 | 66FDY99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2017 | 66FDY99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2017 | 66FDY99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2017 | 66FDY99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2017 | 66FDY99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2017 | 66FDY99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/7/2016 | 60RCB16PHENTERMINE (ANOREXIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/7/2016 | 60KCA15TIBOLONE (ANABOLIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/22/2016 | 60CDA57PSEUDOEPHEDRINE (ADRENERGIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/30/2012 | 60CDY10PSEUDOEPHEDRINE HCL (ADRENERGIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/26/2012 | 65VAA15DIAZEPAM (SEDATIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/26/2012 | 62LDA37QUININE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/9/2006 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/13/2005 | 60CCB57PSEUDOEPHEDRINE (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/6/2005 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/24/2005 | 60RIB99ANOREXIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Productos Medix, S.A. de C.V.'s FDA import refusal history?
Productos Medix, S.A. de C.V. (FEI: 3009932533) has 41 FDA import refusal record(s) in our database, spanning from 3/24/2005 to 12/9/2025.
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 Medix, S.A. de C.V.'s FEI number is 3009932533.
What types of violations has Productos Medix, S.A. de C.V. received?
Productos Medix, 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 Productos Medix, S.A. de C.V. come from?
All FDA import refusal data for Productos Medix, 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.