ImportRefusal LogoImportRefusal

Thersby Group The

⚠️ Moderate Risk

FEI: 3003588864 • Stockton-on-Tees, Cleveland • UNITED KINGDOM

FEI

FEI Number

3003588864

📍

Location

Stockton-on-Tees, Cleveland

🇬🇧
🏢

Address

77 Norton Road, CLE, Stockton-on-Tees, Cleveland, United Kingdom

Moderate Risk

FDA Import Risk Assessment

33.7
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
12/16/2011
Latest Refusal
11/1/2006
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
3.9×10%
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).

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

Refusal History

DateProductViolationsDivision
12/16/2011
62LBA99ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C.
483DRUG NAME
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/1/2006
64TCP99IMMUNOSUPPRESS N.E.C.
118NOT LISTED
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Thersby Group The's FDA import refusal history?

Thersby Group The (FEI: 3003588864) has 2 FDA import refusal record(s) in our database, spanning from 11/1/2006 to 12/16/2011.

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. Thersby Group The's FEI number is 3003588864.

What types of violations has Thersby Group The received?

Thersby Group The 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 Thersby Group The come from?

All FDA import refusal data for Thersby Group The 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.