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Blue Sky World

✅ Low Risk

FEI: 3003939569 • Inverness • UNITED KINGDOM

FEI

FEI Number

3003939569

📍

Location

Inverness

🇬🇧
🏢

Address

Beechwood Buisness Park North, , Inverness, , United Kingdom

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
1/27/2004
Latest Refusal
1/27/2004
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

4791×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

Refusal History

DateProductViolationsDivision
1/27/2004
75CGAGLUCOSE OXIDASE, GLUCOSE
341REGISTERED
479DV QUALITY
New York District Office (NYK-DO)

Frequently Asked Questions

What is Blue Sky World's FDA import refusal history?

Blue Sky World (FEI: 3003939569) has 1 FDA import refusal record(s) in our database, spanning from 1/27/2004 to 1/27/2004.

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. Blue Sky World's FEI number is 3003939569.

What types of violations has Blue Sky World received?

Blue Sky World has been cited for 2 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 Blue Sky World come from?

All FDA import refusal data for Blue Sky World 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.