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Sundrops Ltd

⚠️ Moderate Risk

FEI: 3007543406 • Huddersfield, KIR • UNITED KINGDOM

FEI

FEI Number

3007543406

📍

Location

Huddersfield, KIR

🇬🇧
🏢

Address

Manchester Road, , Huddersfield, KIR, United Kingdom

Moderate Risk

FDA Import Risk Assessment

33.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
6/30/2009
Latest Refusal
6/30/2009
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1972×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

4712×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

Refusal History

DateProductViolationsDivision
6/30/2009
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
197COSM COLOR
471CSTIC LBLG
Baltimore District Office (BLT-DO)
6/30/2009
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
197COSM COLOR
471CSTIC LBLG
Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is Sundrops Ltd's FDA import refusal history?

Sundrops Ltd (FEI: 3007543406) has 2 FDA import refusal record(s) in our database, spanning from 6/30/2009 to 6/30/2009.

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. Sundrops Ltd's FEI number is 3007543406.

What types of violations has Sundrops Ltd received?

Sundrops Ltd 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 Sundrops Ltd come from?

All FDA import refusal data for Sundrops Ltd 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.