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Zymetech Ltd

Low Risk

FEI: 3003976024 • Reykjavik • ICELAND

FEI

FEI Number

3003976024

📍

Location

Reykjavik

🇮🇸

Country

ICELAND
🏢

Address

Skildinganesi 29, , Reykjavik, , Iceland

Low Risk

FDA Import Risk Assessment

24.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
5/30/2006
Latest Refusal
11/18/2002
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
5.7×10%
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

4711×

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.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4881×

HEALTH C

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 bears an unauthorized nutrient content/health claim.

Refusal History

DateProductViolationsDivision
5/30/2006
53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
New Orleans District Office (NOL-DO)
11/18/2002
66VCL99MISCELLANEOUS PATENT MEDICINES, ETC.
488HEALTH C
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Zymetech Ltd's FDA import refusal history?

Zymetech Ltd (FEI: 3003976024) has 2 FDA import refusal record(s) in our database, spanning from 11/18/2002 to 5/30/2006.

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. Zymetech Ltd's FEI number is 3003976024.

What types of violations has Zymetech Ltd received?

Zymetech Ltd 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 Zymetech Ltd come from?

All FDA import refusal data for Zymetech 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.