DANKEL MEDICAL SAPI DE CV
⚠️ High Risk
FEI: 3012901937 • Guanajuato • MEXICO
FEI Number
3012901937
Location
Guanajuato
Country
MEXICOAddress
Av San Martin Obispo No, , Guanajuato, , 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/27/2024 | 60WDA16MEBENDAZOLE (ANTHELMINTIC) | Division of Southeast Imports (DSEI) | |
| 2/27/2024 | 64LCY19DEXAMETHASONE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 10/3/2023 | 64LDK19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/22/2021 | 60NCL14TESTOSTERONE (ANDROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2017 | 64LAO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is DANKEL MEDICAL SAPI DE CV's FDA import refusal history?
DANKEL MEDICAL SAPI DE CV (FEI: 3012901937) has 5 FDA import refusal record(s) in our database, spanning from 2/22/2017 to 2/27/2024.
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. DANKEL MEDICAL SAPI DE CV's FEI number is 3012901937.
What types of violations has DANKEL MEDICAL SAPI DE CV received?
DANKEL MEDICAL SAPI 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 DANKEL MEDICAL SAPI DE CV come from?
All FDA import refusal data for DANKEL MEDICAL SAPI 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.