Johnson & Johnson Consumer Inc
⚠️ High Risk
FEI: 2010632 • Los Angeles, CA • UNITED STATES
FEI Number
2010632
Location
Los Angeles, CA
Country
UNITED STATESAddress
5760 W 96th St, , Los Angeles, CA, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/17/2024 | 61SBL01COAL TAR (ANTI-ECZEMATIC) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 12/22/2020 | 60LAE01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 1/7/2013 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 7/26/2012 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/26/2012 | 66PBJ07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of Southeast Imports (DSEI) | |
| 7/26/2012 | 66PBJ07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of Southeast Imports (DSEI) | |
| 7/26/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 12/13/2004 | 63VDL02HYDROQUINONE (DEPIGMENTOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Johnson & Johnson Consumer Inc's FDA import refusal history?
Johnson & Johnson Consumer Inc (FEI: 2010632) has 8 FDA import refusal record(s) in our database, spanning from 12/13/2004 to 12/17/2024.
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 Consumer Inc's FEI number is 2010632.
What types of violations has Johnson & Johnson Consumer Inc received?
Johnson & Johnson Consumer Inc has been cited for 2 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 Consumer Inc come from?
All FDA import refusal data for Johnson & Johnson Consumer Inc 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.