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Centro Radiologia Especializado Sa

⚠️ Moderate Risk

FEI: 3004103991 • Santiago • DOMINICAN REPUBLIC

FEI

FEI Number

3004103991

📍

Location

Santiago

🇩🇴
🏢

Address

Aev Bartolome Colon Texas Modulo, , Santiago, , 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
10/15/2003
Latest Refusal
10/15/2003
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

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

Refusal History

DateProductViolationsDivision
10/15/2003
90ITYASSEMBLY, TUBE HOUSING, X-RAY, DIAGNOSTIC
237NO PMA
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Centro Radiologia Especializado Sa's FDA import refusal history?

Centro Radiologia Especializado Sa (FEI: 3004103991) has 1 FDA import refusal record(s) in our database, spanning from 10/15/2003 to 10/15/2003.

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. Centro Radiologia Especializado Sa's FEI number is 3004103991.

What types of violations has Centro Radiologia Especializado Sa received?

Centro Radiologia Especializado Sa 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 Centro Radiologia Especializado Sa come from?

All FDA import refusal data for Centro Radiologia Especializado Sa 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.