Merlo Avelino Pascual
⚠️ Moderate Risk
FEI: 3006020387 • Buenos Aires • ARGENTINA
FEI Number
3006020387
Location
Buenos Aires
Country
ARGENTINAAddress
Ortega Y Gasset 1685, , Buenos Aires, , Argentina
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
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 |
|---|---|---|---|
| 12/28/2006 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/28/2006 | 62QDR99ANTI-RHEUMATIC N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/28/2006 | 61MCA06CLONAZEPAM (ANTI-CONVULSANT) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/28/2006 | 61XCA17DIMETHINDENE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Merlo Avelino Pascual's FDA import refusal history?
Merlo Avelino Pascual (FEI: 3006020387) has 4 FDA import refusal record(s) in our database, spanning from 12/28/2006 to 12/28/2006.
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. Merlo Avelino Pascual's FEI number is 3006020387.
What types of violations has Merlo Avelino Pascual received?
Merlo Avelino Pascual has been cited for 1 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 Merlo Avelino Pascual come from?
All FDA import refusal data for Merlo Avelino Pascual 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.