Johnson And Johnson
⚠️ Moderate Risk
FEI: 3004132514 • Issy Cedex • FRANCE
FEI Number
3004132514
Location
Issy Cedex
Country
FRANCEAddress
Rue Camille, , Issy Cedex, , France
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/15/2006 | 53MA01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 2/15/2006 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) | |
| 2/15/2006 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) | |
| 2/15/2006 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Johnson And Johnson's FDA import refusal history?
Johnson And Johnson (FEI: 3004132514) has 4 FDA import refusal record(s) in our database, spanning from 2/15/2006 to 2/15/2006.
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 And Johnson's FEI number is 3004132514.
What types of violations has Johnson And Johnson received?
Johnson And 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 And Johnson come from?
All FDA import refusal data for Johnson And 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.