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Arrow Africa

⚠️ Moderate Risk

FEI: 3003432537 • Sandton, Gauteng • SOUTH AFRICA

FEI

FEI Number

3003432537

📍

Location

Sandton, Gauteng

🇿🇦
🏢

Address

22 Witkoppen Road, , Sandton, Gauteng, South Africa

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/21/2003
Latest Refusal
11/21/2003
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

2261×

DEVICE GMP

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

Refusal History

DateProductViolationsDivision
11/21/2003
79GAPSUTURE, NONABSORBABLE, SILK
226DEVICE GMP
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Arrow Africa's FDA import refusal history?

Arrow Africa (FEI: 3003432537) has 1 FDA import refusal record(s) in our database, spanning from 11/21/2003 to 11/21/2003.

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. Arrow Africa's FEI number is 3003432537.

What types of violations has Arrow Africa received?

Arrow Africa 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 Africa come from?

All FDA import refusal data for Arrow Africa 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.