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Tillomed Laboratories Ltd.,

⚠️ Moderate Risk

FEI: 3015859457 • Great Marlings, Luton • UNITED KINGDOM

FEI

FEI Number

3015859457

📍

Location

Great Marlings, Luton

🇬🇧
🏢

Address

220 Butterfield, , Great Marlings, Luton, United Kingdom

Moderate Risk

FDA Import Risk Assessment

46.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
11/18/2022
Latest Refusal
8/26/2020
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
21.7×20%
Frequency
9.0×10%
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

752×

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).

Refusal History

DateProductViolationsDivision
11/18/2022
66VCC99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
8/26/2020
61NCF85DULOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Tillomed Laboratories Ltd.,'s FDA import refusal history?

Tillomed Laboratories Ltd., (FEI: 3015859457) has 2 FDA import refusal record(s) in our database, spanning from 8/26/2020 to 11/18/2022.

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. Tillomed Laboratories Ltd.,'s FEI number is 3015859457.

What types of violations has Tillomed Laboratories Ltd., received?

Tillomed Laboratories 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 Tillomed Laboratories Ltd., come from?

All FDA import refusal data for Tillomed Laboratories 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.