UNITED STATES
UNITED STA
FDA import refusal data for products from UNITED STATES
Common Violations
Top Firms
| # | Firm Name | Risk | Refusals |
|---|---|---|---|
| 1 | Warsaw Orthopedic, Inc. Warsaw | Risk: 68.1 | 343 |
| 2 | Risk: 59.5 | 308 | |
| 3 | Sanofi-Aventis US LLC Saint Louis | Risk: 70.4 | 222 |
| 4 | Johnson & Johnson Vision Care, Inc. Jacksonville | Risk: 77.5 | 220 |
| 5 | Mars Petcare Victorville | Risk: 73.3 | 200 |
| 6 | Aplicare Products, LLC Meriden | Risk: 84.6 | 183 |
| 7 | Alcon Research LLC Duluth | Risk: 65.3 | 162 |
| 8 | Risk: 56.5 | 113 | |
| 9 | Risk: 57.2 | 99 | |
| 10 | The Estee Lauder Inc. Melville | Risk: 57.8 | 97 |
| 11 | Risk: 57.5 | 97 | |
| 12 | Maui Jim, Inc. Peoria | Risk: 48.4 | 91 |
| 13 | Risk: 55.4 | 90 | |
| 14 | Pd Products Llc West Hills | Risk: 54.0 | 90 |
| 15 | Bausch & Lomb Incorporated Rochester | Risk: 66.1 | 83 |
| 16 | CooperVision, Inc. West Henrietta | Risk: 59.0 | 82 |
| 17 | Merck & Co. Inc Rahway | Risk: 65.3 | 77 |
| 18 | Pfizer Inc. New York | Risk: 75.5 | 74 |
| 19 | Mylan Pharmaceuticals Inc. San Carlos | Risk: 66.8 | 74 |
| 20 | Medtronic Inc Mounds View | Risk: 59.2 | 72 |
Frequently Asked Questions
How many FDA import refusals are from UNITED STATES?
According to FDA records, there have been 15,377 import refusals for products originating from UNITED STATES, involving 4558 firms.
What products from UNITED STATES are commonly refused by the FDA?
Products from UNITED STATES 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 UNITED STATES are unsafe?
Not necessarily. An import refusal indicates a specific shipment appeared to violate FDA requirements at the time of inspection. Many UNITED STATES 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 UNITED STATES?
Our database includes FDA import refusals for UNITED STATES through 1/22/2026. 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.