La Tia Trini, S.A. de C.V.
⚠️ Moderate Risk
FEI: 3010213465 • Tlaquepaque, Jalisco • MEXICO
FEI Number
3010213465
Location
Tlaquepaque, Jalisco
Country
MEXICOAddress
Camino A Los Capulines No. 8, Pueblo Santa Anita, San Pedro Tlaquepaque, Tlaquepaque, Jalisco, 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
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).
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/5/2018 | 33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | Division of Southwest Imports (DSWI) | |
| 5/16/2018 | 36CGT04HONEY | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 8/8/2011 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/8/2011 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/8/2011 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/8/2011 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/8/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/8/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is La Tia Trini, S.A. de C.V.'s FDA import refusal history?
La Tia Trini, S.A. de C.V. (FEI: 3010213465) has 8 FDA import refusal record(s) in our database, spanning from 8/8/2011 to 11/5/2018.
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. La Tia Trini, S.A. de C.V.'s FEI number is 3010213465.
What types of violations has La Tia Trini, S.A. de C.V. received?
La Tia Trini, S.A. de 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 La Tia Trini, S.A. de C.V. come from?
All FDA import refusal data for La Tia Trini, 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.