ELANCO SALUD ANIMAL SA DE CV
⚠️ High Risk
FEI: 3019771900 • Zapopan, Jalisco • MEXICO
FEI Number
3019771900
Location
Zapopan, Jalisco
Country
MEXICOAddress
Boulevard Puerta De Hierro 5153, Col. Puerta De Hierro, Zapopan, Zapopan, 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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
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 |
|---|---|---|---|
| 12/12/2024 | 66VOY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 12/12/2024 | 66VOY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 11/1/2024 | 65RPL99REPLENISHER N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 10/1/2024 | 60ZPQ99ANTIPARASITIC, N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/23/2024 | 65CRP99NUTRIENT/TONIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/23/2024 | 65CRP99NUTRIENT/TONIC N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ELANCO SALUD ANIMAL SA DE CV's FDA import refusal history?
ELANCO SALUD ANIMAL SA DE CV (FEI: 3019771900) has 6 FDA import refusal record(s) in our database, spanning from 9/23/2024 to 12/12/2024.
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. ELANCO SALUD ANIMAL SA DE CV's FEI number is 3019771900.
What types of violations has ELANCO SALUD ANIMAL SA DE CV received?
ELANCO SALUD ANIMAL SA DE CV has been cited for 5 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 ELANCO SALUD ANIMAL SA DE CV come from?
All FDA import refusal data for ELANCO SALUD ANIMAL 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.