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Av Circunvalacion

⚠️ Moderate Risk

FEI: 3007559653 • Santo Domingo • DOMINICAN REPUBLIC

FEI

FEI Number

3007559653

📍

Location

Santo Domingo

🇩🇴
🏢

Address

Los Rios, , Santo Domingo, , Dominican Republic

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/3/2009
Latest Refusal
9/3/2009
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

DateProductViolationsDivision
9/3/2009
54ARK05VITAMIN B12 (CYANOCOBALAMIN)
27DRUG GMPS
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Av Circunvalacion's FDA import refusal history?

Av Circunvalacion (FEI: 3007559653) has 1 FDA import refusal record(s) in our database, spanning from 9/3/2009 to 9/3/2009.

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. Av Circunvalacion's FEI number is 3007559653.

What types of violations has Av Circunvalacion received?

Av Circunvalacion 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 Av Circunvalacion come from?

All FDA import refusal data for Av Circunvalacion 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.