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THERAPAK PHARMA SERVICE LTD

⚠️ Moderate Risk

FEI: 3012377136 • Hayes • UNITED KINGDOM

FEI

FEI Number

3012377136

📍

Location

Hayes

🇬🇧
🏢

Address

Unit 4, Waterway Busines, Hayes, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/30/2018
Latest Refusal
9/30/2018
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

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).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
9/30/2018
79GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
118NOT LISTED
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is THERAPAK PHARMA SERVICE LTD's FDA import refusal history?

THERAPAK PHARMA SERVICE LTD (FEI: 3012377136) has 1 FDA import refusal record(s) in our database, spanning from 9/30/2018 to 9/30/2018.

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. THERAPAK PHARMA SERVICE LTD's FEI number is 3012377136.

What types of violations has THERAPAK PHARMA SERVICE LTD received?

THERAPAK PHARMA SERVICE 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 THERAPAK PHARMA SERVICE LTD come from?

All FDA import refusal data for THERAPAK PHARMA SERVICE 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.