Johnson & Johnson Consumer Inc
⚠️ High Risk
FEI: 3000265603 • New Brunswick, NJ • UNITED STATES
FEI Number
3000265603
Location
New Brunswick, NJ
Country
UNITED STATESAddress
1 Johnson And Johnson Plz, , New Brunswick, NJ, 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).
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.
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/21/2025 | 66PBQ05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of Northern Border Imports (DNBI) | |
| 12/18/2024 | 85HEBTAMPON, MENSTRUAL, UNSCENTED | Division of Southeast Imports (DSEI) | |
| 10/27/2020 | 79OVNSUTURE KIT | Division of Southeast Imports (DSEI) | |
| 8/22/2020 | 76JESFLOSS, DENTAL | Division of Southeast Imports (DSEI) | |
| 8/22/2020 | 54FCY63SOAPWORT (YUCCA ROOT, AGAVE), (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/7/2019 | 62CBL41MINOXIDIL (ANTI-HYPERTENSIVE) | Division of Northern Border Imports (DNBI) | |
| 5/26/2017 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Northern Border Imports (DNBI) | |
| 4/20/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Florida District Office (FLA-DO) | |
| 1/26/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/22/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 8/15/2014 | 79GAPSUTURE, NONABSORBABLE, SILK | New York District Office (NYK-DO) | |
| 12/9/2009 | 60LAF01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Johnson & Johnson Consumer Inc's FDA import refusal history?
Johnson & Johnson Consumer Inc (FEI: 3000265603) has 12 FDA import refusal record(s) in our database, spanning from 12/9/2009 to 1/21/2025.
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 3000265603.
What types of violations has Johnson & Johnson Consumer Inc received?
Johnson & Johnson Consumer Inc has been cited for 9 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.