Johnson & Johnson Gmbh Ltd
⚠️ Moderate Risk
FEI: 3011556240 • Maidenhead, Berkshire • UNITED KINGDOM
FEI Number
3011556240
Location
Maidenhead, Berkshire
Country
UNITED KINGDOMAddress
2 Foundation Park, Roxborough Way, Maidenhead, Berkshire, 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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
DRUG COLOR
The article appears to be a color additive the intended use of which is for the purpose of coloring only, and its packaging and labeling do not conform to regulations issued under section 721.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/4/2019 | 61HBL99ANTI-BACTERIAL, N.E.C. | Division of Northeast Imports (DNEI) | |
| 7/22/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 7/22/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 7/22/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 7/22/2016 | 53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Division of Northeast Imports (DNEI) | |
| 7/22/2016 | 53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Johnson & Johnson Gmbh Ltd's FDA import refusal history?
Johnson & Johnson Gmbh Ltd (FEI: 3011556240) has 6 FDA import refusal record(s) in our database, spanning from 7/22/2016 to 1/4/2019.
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 Gmbh Ltd's FEI number is 3011556240.
What types of violations has Johnson & Johnson Gmbh Ltd received?
Johnson & Johnson Gmbh Ltd has been cited for 7 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 Gmbh Ltd come from?
All FDA import refusal data for Johnson & Johnson Gmbh 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.