Johnson & Johnson
⚠️ Moderate Risk
FEI: 3006124298 • Markham, Ontario • CANADA
FEI Number
3006124298
Location
Markham, Ontario
Country
CANADAAddress
88 McNabb St, , Markham, Ontario, Canada
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/12/2021 | 56FBJ13BACITRACIN ZINC (PEPTIDES) | Division of Northern Border Imports (DNBI) | |
| 1/4/2021 | 60LCA01ACETAMINOPHEN (ANALGESIC) | Division of Northern Border Imports (DNBI) | |
| 11/30/2020 | 62GDB99ANTI-INFLAMMATORY N.E.C. | Division of West Coast Imports (DWCI) | |
| 10/19/2020 | 62WMB08ZINC CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 10/19/2020 | 62WMB08ZINC CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 10/19/2020 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 1/28/2019 | 56FBY30POLYMYXIN B SULFATE (PEPTIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/9/2018 | 56FAK30POLYMYXIN B SULFATE (PEPTIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Johnson & Johnson's FDA import refusal history?
Johnson & Johnson (FEI: 3006124298) has 8 FDA import refusal record(s) in our database, spanning from 7/9/2018 to 7/12/2021.
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's FEI number is 3006124298.
What types of violations has Johnson & Johnson received?
Johnson & Johnson has been cited for 4 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 come from?
All FDA import refusal data for Johnson & Johnson 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.