ImportRefusal LogoImportRefusal

Angela Rosario

⚠️ Moderate Risk

FEI: 3004119145 • Santo Domingo • DOMINICAN REPUBLIC

FEI

FEI Number

3004119145

📍

Location

Santo Domingo

🇩🇴
🏢

Address

Santo Domingo, , Santo Domingo, , Dominican Republic

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
1
Unique Violations
10/20/2003
Latest Refusal
10/20/2003
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

752×

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

DateProductViolationsDivision
10/20/2003
61FCB54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)
10/20/2003
62GCB99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Angela Rosario's FDA import refusal history?

Angela Rosario (FEI: 3004119145) has 2 FDA import refusal record(s) in our database, spanning from 10/20/2003 to 10/20/2003.

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. Angela Rosario's FEI number is 3004119145.

What types of violations has Angela Rosario received?

Angela Rosario 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 Angela Rosario come from?

All FDA import refusal data for Angela Rosario 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.