Zirin Laboratories De Mexico
⚠️ High Risk
FEI: 3009589222 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3009589222
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Rio Yapura 149, Col. Argentina Poniente, Miguel Hidalgo, Ciudad De Mexico, Ciudad de Mexico, 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
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).
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.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/10/2024 | 66VLY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 11/1/2024 | 65RPL99REPLENISHER N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 11/1/2024 | 65RPL99REPLENISHER N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 9/28/2022 | 54YNR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2022 | 54YNK99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2022 | 54YNK99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/20/2012 | 66YRK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Zirin Laboratories De Mexico's FDA import refusal history?
Zirin Laboratories De Mexico (FEI: 3009589222) has 7 FDA import refusal record(s) in our database, spanning from 7/20/2012 to 12/10/2024.
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. Zirin Laboratories De Mexico's FEI number is 3009589222.
What types of violations has Zirin Laboratories De Mexico received?
Zirin Laboratories De Mexico has been cited for 4 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 Zirin Laboratories De Mexico come from?
All FDA import refusal data for Zirin Laboratories 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.