Cross Vetpharm Group Ltd.
⚠️ High Risk
FEI: 3004126741 • Dublin 24, Co. DUBLIN • IRELAND
FEI Number
3004126741
Location
Dublin 24, Co. DUBLIN
Country
IRELANDAddress
Broomhill Road, , Dublin 24, Co. DUBLIN, Ireland
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).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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 |
|---|---|---|---|
| 12/21/2012 | 56DDR41NEOMYCIN SULFATE (AMINOGLYCOSIDES) | New Orleans District Office (NOL-DO) | |
| 3/14/2011 | 60WOS99ANTHELMINTIC, N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 3/14/2011 | 60WLK99ANTHELMINTIC, N.E.C. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 7/29/2010 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Los Angeles District Office (LOS-DO) | |
| 7/29/2010 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Los Angeles District Office (LOS-DO) | |
| 7/14/2010 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/23/2010 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Los Angeles District Office (LOS-DO) | |
| 6/23/2010 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Los Angeles District Office (LOS-DO) | |
| 6/23/2010 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Los Angeles District Office (LOS-DO) | |
| 5/11/2010 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 5/11/2010 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 4/7/2010 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/7/2010 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/8/2009 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 8/22/2008 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/16/2008 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/16/2008 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/8/2008 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/3/2008 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/12/2007 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/10/2007 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Los Angeles District Office (LOS-DO) | |
| 10/17/2006 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/10/2006 | 64EBL99ENZYME N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 10/4/2005 | 56BKS52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Cross Vetpharm Group Ltd.'s FDA import refusal history?
Cross Vetpharm Group Ltd. (FEI: 3004126741) has 24 FDA import refusal record(s) in our database, spanning from 10/4/2005 to 12/21/2012.
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. Cross Vetpharm Group Ltd.'s FEI number is 3004126741.
What types of violations has Cross Vetpharm Group Ltd. received?
Cross Vetpharm Group Ltd. 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 Cross Vetpharm Group Ltd. come from?
All FDA import refusal data for Cross Vetpharm Group Ltd. 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.