Upjohn Manufacturing Ireland Unlimited Company
⚠️ Moderate Risk
FEI: 3003382089 • Cork, Co. CORK • IRELAND
FEI Number
3003382089
Location
Cork, Co. CORK
Country
IRELANDAddress
Little Island, , Cork, Co. CORK, Ireland
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).
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.
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 |
|---|---|---|---|
| 10/2/2014 | 61WCY59VORICONAZOLE | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 10/12/2011 | 61JCC08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/30/2007 | 61JIS99ANTI-CHOLESTEREMIC, N.E.C. | 16DIRECTIONS | Seattle District Office (SEA-DO) |
| 9/1/2006 | 62OCP14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/1/2006 | 61JCP08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/8/2003 | 60LCB83CELECOXIB (ANALGESIC) | Los Angeles District Office (LOS-DO) | |
| 3/13/2003 | 61JCS08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | New York District Office (NYK-DO) | |
| 3/13/2003 | 61JCS08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Upjohn Manufacturing Ireland Unlimited Company's FDA import refusal history?
Upjohn Manufacturing Ireland Unlimited Company (FEI: 3003382089) has 8 FDA import refusal record(s) in our database, spanning from 3/13/2003 to 10/2/2014.
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. Upjohn Manufacturing Ireland Unlimited Company's FEI number is 3003382089.
What types of violations has Upjohn Manufacturing Ireland Unlimited Company received?
Upjohn Manufacturing Ireland Unlimited Company 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 Upjohn Manufacturing Ireland Unlimited Company come from?
All FDA import refusal data for Upjohn Manufacturing Ireland Unlimited Company 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.