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Immunodiagnostic Systems Limited

⚠️ Moderate Risk

FEI: 3002485711 • Boldon Colliery, Tyne and Wear • UNITED KINGDOM

FEI

FEI Number

3002485711

📍

Location

Boldon Colliery, Tyne and Wear

🇬🇧
🏢

Address

10 Didcot Way, , Boldon Colliery, Tyne and Wear, United Kingdom

Moderate Risk

FDA Import Risk Assessment

33.1
LowModerateHighCritical

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

Statistics

5
Total Refusals
3
Unique Violations
10/25/2013
Latest Refusal
9/5/2013
Earliest Refusal

Score Breakdown

Violation Severity
48.6×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

1185×

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).

3415×

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).

5084×

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
10/25/2013
78PEVDIALYSIS ADMINISTRATION KITS (CONVENIENCE KIT)
118NOT LISTED
341REGISTERED
508NO 510(K)
New Orleans District Office (NOL-DO)
10/25/2013
88NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS
118NOT LISTED
341REGISTERED
New Orleans District Office (NOL-DO)
9/5/2013
75JMMCOLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE
118NOT LISTED
341REGISTERED
508NO 510(K)
New Orleans District Office (NOL-DO)
9/5/2013
75MRGSYSTEM, TEST, VITAMIN D
118NOT LISTED
341REGISTERED
508NO 510(K)
New Orleans District Office (NOL-DO)
9/5/2013
75NEOSYSTEM, TEST, OSTEOCALCIN
118NOT LISTED
341REGISTERED
508NO 510(K)
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Immunodiagnostic Systems Limited's FDA import refusal history?

Immunodiagnostic Systems Limited (FEI: 3002485711) has 5 FDA import refusal record(s) in our database, spanning from 9/5/2013 to 10/25/2013.

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. Immunodiagnostic Systems Limited's FEI number is 3002485711.

What types of violations has Immunodiagnostic Systems Limited received?

Immunodiagnostic Systems Limited 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 Immunodiagnostic Systems Limited come from?

All FDA import refusal data for Immunodiagnostic Systems Limited 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.