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Theramed Ltd

✅ Low Risk

FEI: 3004153308 • Halesworth • UNITED KINGDOM

FEI

FEI Number

3004153308

📍

Location

Halesworth

🇬🇧
🏢

Address

3 Churchwood Lodge Rd, , Halesworth, , United Kingdom

Low Risk

FDA Import Risk Assessment

19.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
8/29/2012
Latest Refusal
8/29/2012
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

3412×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
8/29/2012
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
341REGISTERED
Southwest Import District Office (SWI-DO)
8/29/2012
53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
341REGISTERED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Theramed Ltd's FDA import refusal history?

Theramed Ltd (FEI: 3004153308) has 2 FDA import refusal record(s) in our database, spanning from 8/29/2012 to 8/29/2012.

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. Theramed Ltd's FEI number is 3004153308.

What types of violations has Theramed Ltd received?

Theramed Ltd has been cited for 1 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 Theramed Ltd come from?

All FDA import refusal data for Theramed 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.