Johnson & Johnson Ltd
⚠️ Moderate Risk
FEI: 1000455924 • Maidenhead • UNITED KINGDOM
FEI Number
1000455924
Location
Maidenhead
Country
UNITED KINGDOMAddress
Foundation Park Roxborough Way, , Maidenhead, , United Kingdom
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/28/2022 | 64LAY38HYDROCORTISONE ACETATE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 11/12/2019 | 61HBL99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/12/2019 | 61HBL99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/12/2019 | 61HBL99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/2/2011 | 76EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/26/2010 | 79MGQDRESSING, WOUND AND BURN, HYDROGEL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Johnson & Johnson Ltd's FDA import refusal history?
Johnson & Johnson Ltd (FEI: 1000455924) has 7 FDA import refusal record(s) in our database, spanning from 7/26/2010 to 3/28/2022.
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. Johnson & Johnson Ltd's FEI number is 1000455924.
What types of violations has Johnson & Johnson Ltd received?
Johnson & Johnson 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 & Johnson Ltd come from?
All FDA import refusal data for Johnson & Johnson 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.