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Allicin Internatio

⚠️ Moderate Risk

FEI: 3004150994 • Catsfield Bat • UNITED KINGDOM

FEI

FEI Number

3004150994

📍

Location

Catsfield Bat

🇬🇧
🏢

Address

Saberdene Hse Chur, , Catsfield Bat, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

42.3
LowModerateHighCritical

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

Statistics

8
Total Refusals
3
Unique Violations
6/22/2011
Latest Refusal
10/26/2005
Earliest Refusal

Score Breakdown

Violation Severity
75.7×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
14.1×10%
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

757×

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).

164×

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.

1183×

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).

Refusal History

DateProductViolationsDivision
6/22/2011
61HAL99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
16DIRECTIONS
75UNAPPROVED
Cincinnati District Office (CIN-DO)
6/22/2011
61HAJ99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
16DIRECTIONS
75UNAPPROVED
Cincinnati District Office (CIN-DO)
6/22/2011
61HAJ99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
16DIRECTIONS
75UNAPPROVED
Cincinnati District Office (CIN-DO)
6/17/2011
56YAJ99ANTIBIOTIC N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
6/17/2011
56YAJ99ANTIBIOTIC N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
6/17/2011
56YAL99ANTIBIOTIC N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
6/17/2011
56YCS99ANTIBIOTIC N.E.C.
16DIRECTIONS
Cincinnati District Office (CIN-DO)
10/26/2005
56YYY99ANTIBIOTIC N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Allicin Internatio's FDA import refusal history?

Allicin Internatio (FEI: 3004150994) has 8 FDA import refusal record(s) in our database, spanning from 10/26/2005 to 6/22/2011.

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. Allicin Internatio's FEI number is 3004150994.

What types of violations has Allicin Internatio received?

Allicin Internatio 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 Allicin Internatio come from?

All FDA import refusal data for Allicin Internatio 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.