Cilag AG
⚠️ High Risk
FEI: 3002806695 • Schaffhausen, Schaffhausen • SWITZERLAND
FEI Number
3002806695
Location
Schaffhausen, Schaffhausen
Country
SWITZERLANDAddress
Hochstrasse 201, , Schaffhausen, Schaffhausen, Switzerland
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/3/2025 | 58MCY27USTEKINUMAB | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/3/2025 | 58DCY41NIVOLUMAB | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 11/25/2016 | 62IIH99ANTI-NEOPLASTIC N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 12/3/2015 | 62VAY57DARUNAVIR (ANTI-VIRAL) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 4/10/2015 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | Division of Northern Border Imports (DNBI) | |
| 11/23/2011 | 55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/23/2011 | 66VIA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 7/1/2009 | 62ZCS08BORTEZOMIB | Chicago District Office (CHI-DO) | |
| 8/15/2007 | 64XCJ12TRETINOIN (KERATOLYTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/30/2006 | 61CCP99ANTI-ANEMIC, N.E.C. | New York District Office (NYK-DO) | |
| 9/18/2005 | 61MCA40TOPIRAMATE (ANTI-CONVULSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/24/2005 | 60LCA99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/22/2005 | 66MIS99TRANQUILIZER N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Cilag AG's FDA import refusal history?
Cilag AG (FEI: 3002806695) has 13 FDA import refusal record(s) in our database, spanning from 3/22/2005 to 9/3/2025.
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. Cilag AG's FEI number is 3002806695.
What types of violations has Cilag AG received?
Cilag AG has been cited for 5 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 Cilag AG come from?
All FDA import refusal data for Cilag AG 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.