IRELAND
IRELAND
FDA import refusal data for products from IRELAND
Common Violations
Top Firms
| # | Firm Name | Risk | Refusals |
|---|---|---|---|
| 1 | Risk: 77.0 | 185 | |
| 2 | Allergan Pharmaceuticals Ireland Westport | Risk: 77.0 | 136 |
| 3 | Risk: 70.0 | 127 | |
| 4 | Mangan Bros Ltd Ennis | Risk: 46.5 | 43 |
| 5 | James McDaid & Sons Ramelton | Risk: 43.0 | 34 |
| 6 | BAUSCH HEALTH IRELAND Waterford | Risk: 54.7 | 31 |
| 7 | Nutri Science Ltd Waterford | Risk: 58.6 | 30 |
| 8 | Bausch & Lomb Ireland Limited Waterford | Risk: 56.0 | 28 |
| 9 | Lake Region Medical, Ltd. New Ross | Risk: 34.3 | 27 |
| 10 | Cross Vetpharm Group Ltd. Dublin 24 | Risk: 51.4 | 24 |
| 11 | Risk: 49.7 | 17 | |
| 12 | Belleek Pottery Ltd Fermanagh | Risk: 56.3 | 17 |
| 13 | Risk: 50.6 | 16 | |
| 14 | STRYKER IRELAND OSTEONICS County Cork | Risk: 30.3 | 15 |
| 15 | Wrights Of Howth Dublin 13 | Risk: 71.1 | 14 |
| 16 | Haleon Ireland Dungarvan Limited Dungarvan | Risk: 46.4 | 14 |
| 17 | James A Barry & Co Ltd Co. Cork | Risk: 40.6 | 13 |
| 18 | Newport Pharmaceuticals Dublin 13 | Risk: 58.4 | 12 |
| 19 | EMA AESTHETIC LIMITED Dublin | Risk: 68.6 | 12 |
| 20 | Tosara Pharma Limited Dublin 13 | Risk: 45.3 | 12 |
Frequently Asked Questions
How many FDA import refusals are from IRELAND?
According to FDA records, there have been 1,613 import refusals for products originating from IRELAND, involving 388 firms.
What products from IRELAND are commonly refused by the FDA?
Products from IRELAND may be refused for various reasons including adulteration, misbranding, lack of proper registration, or failure to meet U.S. safety standards. The specific products vary by firm and time period. View the common violations section on this page for more details.
Does an import refusal mean products from IRELAND are unsafe?
Not necessarily. An import refusal indicates a specific shipment appeared to violate FDA requirements at the time of inspection. Many IRELAND firms successfully import products that meet all FDA requirements. Import refusals help identify and prevent non-compliant products from entering the U.S. market.
How current is the FDA import refusal data for IRELAND?
Our database includes FDA import refusals for IRELAND through 12/22/2025. Data is sourced from the FDA Data Dashboard and updated monthly.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.