INDONESIA
INDONESIA
FDA import refusal data for products from INDONESIA
Common Violations
Top Firms
| # | Firm Name | Risk | Refusals |
|---|---|---|---|
| 1 | PT. Bahari Makmur Sejati Serang | Risk: 95.5 | 434 |
| 2 | P.T. Nipro Indonesia Jaya Karawang | Risk: 80.4 | 388 |
| 3 | Risk: 94.6 | 273 | |
| 4 | PT Bumi Menara Internusa Surabaya | Risk: 82.6 | 219 |
| 5 | Amc Line Express Bekasi | Risk: 72.1 | 157 |
| 6 | Risk: 85.2 | 149 | |
| 7 | PT. Hatindo Makmur Denpasar | Risk: 82.3 | 148 |
| 8 | Risk: 59.6 | 140 | |
| 9 | AMC Bekasi | Risk: 70.5 | 98 |
| 10 | PT. Chen Woo Fishery Makassar | Risk: 71.1 | 82 |
| 11 | Pt. Varia Niaga Nusantara Pasuruan | Risk: 66.8 | 80 |
| 12 | PT. Intimas Surya Denpasar | Risk: 81.7 | 80 |
| 13 | PT. Balinusa Windumas Denpasar | Risk: 63.9 | 79 |
| 14 | P.T. Bonecom Jakarta | Risk: 64.2 | 77 |
| 15 | Risk: 66.6 | 75 | |
| 16 | PT Toba Surimi Industries Deli Serdang | Risk: 65.3 | 73 |
| 17 | PT Awindo International Jakarta | Risk: 69.0 | 65 |
| 18 | PT.Sumber Kalimantan Abadi Balikpapan | Risk: 64.0 | 59 |
| 19 | Risk: 64.4 | 58 | |
| 20 | PT Rex Canning Pasuruan | Risk: 58.2 | 57 |
Frequently Asked Questions
How many FDA import refusals are from INDONESIA?
According to FDA records, there have been 8,844 import refusals for products originating from INDONESIA, involving 1277 firms.
What products from INDONESIA are commonly refused by the FDA?
Products from INDONESIA 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 INDONESIA are unsafe?
Not necessarily. An import refusal indicates a specific shipment appeared to violate FDA requirements at the time of inspection. Many INDONESIA 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 INDONESIA?
Our database includes FDA import refusals for INDONESIA through 12/29/2025. 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.