ImportRefusal LogoImportRefusal

Elemis Ltd Whse & Distribution

⚠️ Moderate Risk

FEI: 3003479339 • Somerset • UNITED KINGDOM

FEI

FEI Number

3003479339

📍

Location

Somerset

🇬🇧
🏢

Address

Unit 1 Crypton Technology Business, , Somerset, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

40.0
LowModerateHighCritical

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

Statistics

6
Total Refusals
4
Unique Violations
10/28/2008
Latest Refusal
2/7/2008
Earliest Refusal

Score Breakdown

Violation Severity
61.4×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

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).

4822×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

23001×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

4741×

COSMETLBLG

It appears the label does not bear the common or usual name of the cosmetic.

Refusal History

DateProductViolationsDivision
10/28/2008
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
482NUTRIT LBL
Florida District Office (FLA-DO)
10/28/2008
53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.
474COSMETLBLG
Florida District Office (FLA-DO)
2/14/2008
54AEF90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN)
2300DIETARYLBL
482NUTRIT LBL
Florida District Office (FLA-DO)
2/7/2008
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Florida District Office (FLA-DO)
2/7/2008
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Florida District Office (FLA-DO)
2/7/2008
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Elemis Ltd Whse & Distribution's FDA import refusal history?

Elemis Ltd Whse & Distribution (FEI: 3003479339) has 6 FDA import refusal record(s) in our database, spanning from 2/7/2008 to 10/28/2008.

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. Elemis Ltd Whse & Distribution's FEI number is 3003479339.

What types of violations has Elemis Ltd Whse & Distribution received?

Elemis Ltd Whse & Distribution has been cited for 4 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 Elemis Ltd Whse & Distribution come from?

All FDA import refusal data for Elemis Ltd Whse & Distribution 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.