Tri State De Mexico
⚠️ Moderate Risk
FEI: 1000628390 • Mexicali, Baja California • MEXICO
FEI Number
1000628390
Location
Mexicali, Baja California
Country
MEXICOAddress
Circulto De Las Misiones 172, , Mexicali, Baja California, Mexico
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
DE/RX KIT
The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is offered for import by other than the manufacturer, and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/12/2010 | 85HFXCLAMP, CIRCUMCISION | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 3/1/2007 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Southwest Import District Office (SWI-DO) | |
| 3/1/2007 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Southwest Import District Office (SWI-DO) | |
| 3/1/2007 | 79KDCINSTRUMENT, SURGICAL, DISPOSABLE | Southwest Import District Office (SWI-DO) | |
| 3/1/2007 | 79KDCINSTRUMENT, SURGICAL, DISPOSABLE | Southwest Import District Office (SWI-DO) | |
| 3/1/2007 | 79MCYKIT, WOUND DRESSING | Southwest Import District Office (SWI-DO) | |
| 3/1/2007 | 79MCYKIT, WOUND DRESSING | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Tri State De Mexico's FDA import refusal history?
Tri State De Mexico (FEI: 1000628390) has 7 FDA import refusal record(s) in our database, spanning from 3/1/2007 to 5/12/2010.
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's FEI number is 1000628390.
What types of violations has Tri State De Mexico received?
Tri State De Mexico 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 come from?
All FDA import refusal data for Tri State De Mexico 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.