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Nasaleze International Limited

⚠️ Moderate Risk

FEI: 3011788145 • Isle of Man, Isle of Man • UNITED KINGDOM

FEI

FEI Number

3011788145

📍

Location

Isle of Man, Isle of Man

🇬🇧
🏢

Address

Second Floor, Shearwater House; Nunnery Mills, Isle of Man, Isle of Man, United Kingdom

Moderate Risk

FDA Import Risk Assessment

41.8
LowModerateHighCritical

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

Statistics

5
Total Refusals
3
Unique Violations
1/7/2010
Latest Refusal
10/10/2008
Earliest Refusal

Score Breakdown

Violation Severity
72.9×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
40.2×10%
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

753×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
1/7/2010
66VIQ99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
Philadelphia District Office (PHI-DO)
1/7/2010
66VIQ99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
Philadelphia District Office (PHI-DO)
11/20/2008
66VBQ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
10/10/2008
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
10/10/2008
66VBR99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Nasaleze International Limited's FDA import refusal history?

Nasaleze International Limited (FEI: 3011788145) has 5 FDA import refusal record(s) in our database, spanning from 10/10/2008 to 1/7/2010.

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. Nasaleze International Limited's FEI number is 3011788145.

What types of violations has Nasaleze International Limited received?

Nasaleze International Limited has been cited for 3 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 Nasaleze International Limited come from?

All FDA import refusal data for Nasaleze International Limited 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.