3M Edumex, S.A. De Cv
⚠️ High Risk
FEI: 3002809016 • Juarez • MEXICO
FEI Number
3002809016
Location
Juarez
Country
MEXICOAddress
Calle Ramon Rivera Lara, Oriente 6620; Chihuahua, Juarez, , 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
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
POSS N/STR
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms
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).
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.
LBLG ADVER
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/16/2025 | 79HMPPAD, EYE | 118NOT LISTED | Division of Southwest Imports (DSWI) |
| 7/16/2025 | 79HMPPAD, EYE | 118NOT LISTED | Division of Southwest Imports (DSWI) |
| 3/25/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | 78STERILITY | Southwest Import District Office (SWI-DO) |
| 3/25/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | 78STERILITY | Southwest Import District Office (SWI-DO) |
| 3/25/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | 78STERILITY | Southwest Import District Office (SWI-DO) |
| 3/25/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | 78STERILITY | Southwest Import District Office (SWI-DO) |
| 3/25/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | 78STERILITY | Southwest Import District Office (SWI-DO) |
| 9/26/2014 | 79KGXTAPE AND BANDAGE, ADHESIVE | Southwest Import District Office (SWI-DO) | |
| 11/23/2010 | 79FXXMASK, SURGICAL | Southwest Import District Office (SWI-DO) | |
| 9/11/2007 | 79KGXTAPE AND BANDAGE, ADHESIVE | 78STERILITY | Southwest Import District Office (SWI-DO) |
| 9/11/2007 | 79KGXTAPE AND BANDAGE, ADHESIVE | 78STERILITY | Southwest Import District Office (SWI-DO) |
| 9/11/2007 | 79KGXTAPE AND BANDAGE, ADHESIVE | 78STERILITY | Southwest Import District Office (SWI-DO) |
| 9/11/2007 | 79KGXTAPE AND BANDAGE, ADHESIVE | 78STERILITY | Southwest Import District Office (SWI-DO) |
| 7/31/2007 | 79KGXTAPE AND BANDAGE, ADHESIVE | 2800POSS N/STR | Southwest Import District Office (SWI-DO) |
| 7/31/2007 | 79KGXTAPE AND BANDAGE, ADHESIVE | 2800POSS N/STR | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is 3M Edumex, S.A. De Cv's FDA import refusal history?
3M Edumex, S.A. De Cv (FEI: 3002809016) has 15 FDA import refusal record(s) in our database, spanning from 7/31/2007 to 7/16/2025.
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. 3M Edumex, S.A. De Cv's FEI number is 3002809016.
What types of violations has 3M Edumex, S.A. De Cv received?
3M Edumex, S.A. De Cv has been cited for 6 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 3M Edumex, S.A. De Cv come from?
All FDA import refusal data for 3M Edumex, S.A. De Cv 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.