Tri State De Mexico SA De R.L. C.V.
⚠️ High Risk
FEI: 3005846326 • Mexicali, Baja California • MEXICO
FEI Number
3005846326
Location
Mexicali, Baja California
Country
MEXICOAddress
Calzada Ciudad De Mexicali 301, Dessarrollo Industrial Colorado, Mexicali, Baja California, 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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
STAINSTEEL
The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/12/2012 | 79LRPTRAY, SURGICAL | Southwest Import District Office (SWI-DO) | |
| 4/12/2012 | 79LRPTRAY, SURGICAL | Southwest Import District Office (SWI-DO) | |
| 9/2/2011 | 79KDCINSTRUMENT, SURGICAL, DISPOSABLE | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 9/1/2011 | 79KDCINSTRUMENT, SURGICAL, DISPOSABLE | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 9/1/2011 | 79KDCINSTRUMENT, SURGICAL, DISPOSABLE | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 8/31/2011 | 79LRQTRACHEOSTOMY AND NASAL SUCTIONING KIT | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 8/31/2011 | 79LRPTRAY, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 12/29/2010 | 79KDCINSTRUMENT, SURGICAL, DISPOSABLE | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 12/29/2010 | 79LRPTRAY, SURGICAL | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 12/29/2010 | 79LROKIT, SURGICAL - GENERAL | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 12/29/2010 | 79KDCINSTRUMENT, SURGICAL, DISPOSABLE | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 12/29/2010 | 79KDCINSTRUMENT, SURGICAL, DISPOSABLE | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 12/29/2010 | 79KDCINSTRUMENT, SURGICAL, DISPOSABLE | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 12/29/2010 | 79LRPTRAY, SURGICAL | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Tri State De Mexico SA De R.L. C.V.'s FDA import refusal history?
Tri State De Mexico SA De R.L. C.V. (FEI: 3005846326) has 14 FDA import refusal record(s) in our database, spanning from 12/29/2010 to 4/12/2012.
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. Tri State De Mexico SA De R.L. C.V.'s FEI number is 3005846326.
What types of violations has Tri State De Mexico SA De R.L. C.V. received?
Tri State De Mexico SA De R.L. 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 Tri State De Mexico SA De R.L. C.V. come from?
All FDA import refusal data for Tri State De Mexico SA De R.L. 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.