JAPAN
JAPAN
FDA import refusal data for products from JAPAN
Common Violations
Top Firms
| # | Firm Name | Risk | Refusals |
|---|---|---|---|
| 1 | NIPRO CORP. Odate | Risk: 81.1 | 414 |
| 2 | Miyuki Elex Co.,Ltd Higashiosaka | Risk: 56.2 | 171 |
| 3 | Risk: 62.3 | 163 | |
| 4 | Daiso Industries Co., Ltd. Higashihiroshima | Risk: 65.3 | 159 |
| 5 | Nipro Medical Industries, Ltd. Tatebayashi | Risk: 72.8 | 156 |
| 6 | Tomey Corporation Nagoya | Risk: 53.3 | 156 |
| 7 | Risk: 72.4 | 133 | |
| 8 | Nipro Corporation Osaka | Risk: 60.8 | 122 |
| 9 | Tosoh Corporation Minato | Risk: 63.4 | 93 |
| 10 | Shibuya Kogyo Co Ltd Kanazawa | Risk: 51.4 | 92 |
| 11 | Risk: 64.8 | 86 | |
| 12 | Nissho Corporation Osaka | Risk: 51.5 | 85 |
| 13 | Sony Corporation Shinagawa | Risk: 58.6 | 73 |
| 14 | Kao Corporation Chuo | Risk: 61.0 | 68 |
| 15 | Risk: 58.2 | 65 | |
| 16 | Risk: 61.3 | 64 | |
| 17 | MIDI Fukui | Risk: 51.0 | 63 |
| 18 | Dentech Corp. Itabashi | Risk: 41.9 | 61 |
| 19 | Aizu Olympus Co., Ltd. Aizuwakamatsu | Risk: 61.3 | 60 |
| 20 | Hug Communication Tokyo | Risk: 45.1 | 54 |
Frequently Asked Questions
How many FDA import refusals are from JAPAN?
According to FDA records, there have been 11,186 import refusals for products originating from JAPAN, involving 2988 firms.
What products from JAPAN are commonly refused by the FDA?
Products from JAPAN 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 JAPAN are unsafe?
Not necessarily. An import refusal indicates a specific shipment appeared to violate FDA requirements at the time of inspection. Many JAPAN 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 JAPAN?
Our database includes FDA import refusals for JAPAN 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.