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Arrow International CR, a.s.

⚠️ Moderate Risk

FEI: 3006425876 • Zdar Nad Sazavou 1 • CZECH REPUBLIC

FEI

FEI Number

3006425876

📍

Location

Zdar Nad Sazavou 1

🇨🇿
🏢

Address

Jamska 2359/47, 1, Zdar Nad Sazavou 1, , Czech Republic

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
7/5/2011
Latest Refusal
7/5/2011
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

472×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
7/5/2011
80FOZCATHETER, INTRAVASCULAR, SHORT TERM
47NON STD
Atlanta District Office (ATL-DO)
7/5/2011
73CAZANESTHESIA CONDUCTION KIT
47NON STD
Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is Arrow International CR, a.s.'s FDA import refusal history?

Arrow International CR, a.s. (FEI: 3006425876) has 2 FDA import refusal record(s) in our database, spanning from 7/5/2011 to 7/5/2011.

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. Arrow International CR, a.s.'s FEI number is 3006425876.

What types of violations has Arrow International CR, a.s. received?

Arrow International CR, a.s. 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 Arrow International CR, a.s. come from?

All FDA import refusal data for Arrow International CR, a.s. 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.