Johnson & Johnson De Mexico S.A. De C.V.
⚠️ Moderate Risk
FEI: 3003027967 • Mexico D.F. • MEXICO
FEI Number
3003027967
Location
Mexico D.F.
Country
MEXICOAddress
Periferico Sur #4629, , Mexico D.F., , Mexico
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
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/9/2005 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 475COSMETLBLG | Southwest Import District Office (SWI-DO) |
| 3/9/2005 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 475COSMETLBLG | Southwest Import District Office (SWI-DO) |
| 6/9/2004 | 53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 473LABELING | Southwest Import District Office (SWI-DO) |
| 6/9/2004 | 76EFWTOOTHBRUSH, MANUAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 10/3/2002 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 10/3/2002 | 53AD01BABY SHAMPOO (BABY PRODUCTS) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 10/3/2002 | 53AD01BABY SHAMPOO (BABY PRODUCTS) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Johnson & Johnson De Mexico S.A. De C.V.'s FDA import refusal history?
Johnson & Johnson De Mexico S.A. De C.V. (FEI: 3003027967) has 7 FDA import refusal record(s) in our database, spanning from 10/3/2002 to 3/9/2005.
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 De Mexico S.A. De C.V.'s FEI number is 3003027967.
What types of violations has Johnson & Johnson De Mexico S.A. De C.V. received?
Johnson & Johnson De Mexico S.A. De C.V. 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 De Mexico S.A. De C.V. come from?
All FDA import refusal data for Johnson & Johnson De Mexico S.A. De C.V. 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.