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Riverside Medical Packaging Company Ltd

⚠️ Moderate Risk

FEI: 3008559295 • Derby, Derbyshire • UNITED KINGDOM

FEI

FEI Number

3008559295

📍

Location

Derby, Derbyshire

🇬🇧
🏢

Address

6 Newmarket Drive, , Derby, Derbyshire, United Kingdom

Moderate Risk

FDA Import Risk Assessment

30.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
5/12/2022
Latest Refusal
5/12/2022
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
12.6×20%
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
5/12/2022
89LXMMANIPULATOR, PLUNGER-LIKE JOINT
118NOT LISTED
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Riverside Medical Packaging Company Ltd's FDA import refusal history?

Riverside Medical Packaging Company Ltd (FEI: 3008559295) has 1 FDA import refusal record(s) in our database, spanning from 5/12/2022 to 5/12/2022.

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. Riverside Medical Packaging Company Ltd's FEI number is 3008559295.

What types of violations has Riverside Medical Packaging Company Ltd received?

Riverside Medical Packaging Company 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 Riverside Medical Packaging Company Ltd come from?

All FDA import refusal data for Riverside Medical Packaging Company 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.