Todo Pak
⚠️ High Risk
FEI: 3004001493 • Guadalajara, Jalisco • MEXICO
FEI Number
3004001493
Location
Guadalajara, Jalisco
Country
MEXICOAddress
Avenida de Las Americas # 1243, Col. AYUNTAMIENTO, Guadalajara, Jalisco, 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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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 |
|---|---|---|---|
| 8/4/2008 | 66VMK99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 8/4/2008 | 68YYY02HORSES ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 8/4/2008 | 66VMK99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 8/4/2008 | 66VMK99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 8/4/2008 | 68YYY02HORSES ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 8/4/2008 | 68YYY02HORSES ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 8/4/2008 | 68YYY02HORSES ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 8/4/2008 | 62LLK47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 8/4/2008 | 68YYY02HORSES ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 8/4/2008 | 68YYY02HORSES ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 8/4/2008 | 60NCY14TESTOSTERONE (ANDROGEN) | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 9/25/2006 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/25/2006 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Todo Pak's FDA import refusal history?
Todo Pak (FEI: 3004001493) has 13 FDA import refusal record(s) in our database, spanning from 9/25/2006 to 8/4/2008.
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. Todo Pak's FEI number is 3004001493.
What types of violations has Todo Pak received?
Todo Pak 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 Todo Pak come from?
All FDA import refusal data for Todo Pak 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.