TOTAL SYSTEM SA DE CV
⚠️ High Risk
FEI: 3009893765 • Tijuana, BC • MEXICO
FEI Number
3009893765
Location
Tijuana, BC
Country
MEXICOAddress
Javier Mina No 1695, Local 7 Zona Rio, Tijuana, BC, 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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is TOTAL SYSTEM SA DE CV's FDA import refusal history?
TOTAL SYSTEM SA DE CV (FEI: 3009893765) has 29 FDA import refusal record(s) in our database, spanning from 12/26/2012 to 12/26/2012.
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. TOTAL SYSTEM SA DE CV's FEI number is 3009893765.
What types of violations has TOTAL SYSTEM SA DE CV received?
TOTAL SYSTEM SA DE CV 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 TOTAL SYSTEM SA DE CV come from?
All FDA import refusal data for TOTAL SYSTEM SA 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.