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Johnson And Johnson (Ireland) Ltd.

⚠️ Moderate Risk

FEI: 3574 • Dublin 24, Co. DUBLIN • IRELAND

FEI

FEI Number

3574

📍

Location

Dublin 24, Co. DUBLIN

🇮🇪

Country

IRELAND
🏢

Address

24 Belgard Road, , Dublin 24, Co. DUBLIN, Ireland

Moderate Risk

FDA Import Risk Assessment

40.5
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
10/5/2018
Latest Refusal
10/18/2011
Earliest Refusal

Score Breakdown

Violation Severity
83.3×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
4.3×10%
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

1231×

BANNED

The article appears to be a banned device.

1971×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

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
10/5/2018
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
197COSM COLOR
Division of Northeast Imports (DNEI)
2/25/2016
86LPMLENSES, SOFT CONTACT, EXTENDED WEAR
508NO 510(K)
Los Angeles District Office (LOS-DO)
10/18/2011
86LPLLENSES, SOFT CONTACT, DAILY WEAR
123BANNED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Johnson And Johnson (Ireland) Ltd.'s FDA import refusal history?

Johnson And Johnson (Ireland) Ltd. (FEI: 3574) has 3 FDA import refusal record(s) in our database, spanning from 10/18/2011 to 10/5/2018.

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. Johnson And Johnson (Ireland) Ltd.'s FEI number is 3574.

What types of violations has Johnson And Johnson (Ireland) Ltd. received?

Johnson And Johnson (Ireland) Ltd. 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 Johnson And Johnson (Ireland) Ltd. come from?

All FDA import refusal data for Johnson And Johnson (Ireland) 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.