Janssen-Cilag S.A. de C.V.
⚠️ Moderate Risk
FEI: 3005888370 • Puebla • MEXICO
FEI Number
3005888370
Location
Puebla
Country
MEXICOAddress
Carratera Federal Mexico-Puebla km 81.5, , 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/25/2021 | 61TCB31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/3/2020 | 60WDA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/7/2019 | 64XCY07TRETINOIN (KERATOLYTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/3/2017 | 61TCA31DOMPERIDONE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Janssen-Cilag S.A. de C.V.'s FDA import refusal history?
Janssen-Cilag S.A. de C.V. (FEI: 3005888370) has 4 FDA import refusal record(s) in our database, spanning from 11/3/2017 to 5/25/2021.
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. Janssen-Cilag S.A. de C.V.'s FEI number is 3005888370.
What types of violations has Janssen-Cilag S.A. de C.V. received?
Janssen-Cilag S.A. de C.V. has been cited for 2 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 S.A. de C.V. come from?
All FDA import refusal data for Janssen-Cilag 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.