Janssen Cilag Sa De Cv
⚠️ Moderate Risk
FEI: 3003319427 • Huejotzingo, Puebla • MEXICO
FEI Number
3003319427
Location
Huejotzingo, Puebla
Country
MEXICOAddress
Carr Fed Mexico Puebla San Km 81 5, Aeropuerto Huejotzingo Puebla, Huejotzingo, Puebla, 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
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/12/2015 | 55CY99NON-METALLIC CONTAINERS AND MATERIALS, N.E.C. | 223FALSE | Cincinnati District Office (CIN-DO) |
| 10/26/2007 | 61WAJ47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Cincinnati District Office (CIN-DO) | |
| 7/3/2007 | 60WDA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/24/2007 | 61HNA43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/24/2006 | 66NCA04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/4/2005 | 66BCF19METHYLPHENIDATE HCL (STIMULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Janssen Cilag Sa De Cv's FDA import refusal history?
Janssen Cilag Sa De Cv (FEI: 3003319427) has 6 FDA import refusal record(s) in our database, spanning from 3/4/2005 to 8/12/2015.
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. Janssen Cilag Sa De Cv's FEI number is 3003319427.
What types of violations has Janssen Cilag Sa De Cv received?
Janssen Cilag Sa De Cv has been cited for 3 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 Janssen Cilag Sa De Cv come from?
All FDA import refusal data for Janssen Cilag Sa De Cv 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.