Ethicon, Inc Div of Johnson & Johnson Medical
⚠️ Moderate Risk
FEI: 1618732 • Arlington, TX • UNITED STATES
FEI Number
1618732
Location
Arlington, TX
Country
UNITED STATESAddress
2500 E Arbrook Blvd, , Arlington, TX, United States
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
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).
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.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/2/2004 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 7/22/2004 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 12/12/2003 | 54FBY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Ethicon, Inc Div of Johnson & Johnson Medical's FDA import refusal history?
Ethicon, Inc Div of Johnson & Johnson Medical (FEI: 1618732) has 3 FDA import refusal record(s) in our database, spanning from 12/12/2003 to 8/2/2004.
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. Ethicon, Inc Div of Johnson & Johnson Medical's FEI number is 1618732.
What types of violations has Ethicon, Inc Div of Johnson & Johnson Medical received?
Ethicon, Inc Div of Johnson & Johnson Medical has been cited for 5 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 Ethicon, Inc Div of Johnson & Johnson Medical come from?
All FDA import refusal data for Ethicon, Inc Div of Johnson & Johnson Medical 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.