ROMANIA
ROMANIA
FDA import refusal data for products from ROMANIA
Common Violations
Top Firms
| # | Firm Name | Risk | Refusals |
|---|---|---|---|
| 1 | MECRO SYSTEM SRL Ramnicu Valcea | Risk: 43.0 | 24 |
| 2 | Sandor Oana Pfa Miercurea-Ciuc | Risk: 36.4 | 14 |
| 3 | Risk: 40.1 | 12 | |
| 4 | Mecro system Bucharest | Risk: 41.6 | 11 |
| 5 | Sic Sa Bucharest | Risk: 43.9 | 9 |
| 6 | SC PERLA HARGHITEI SA Sancraieni | Risk: 35.3 | 8 |
| 7 | S.C. WINFOR TRADE S.R.L. M-Ciuc | Risk: 31.1 | 8 |
| 8 | Terapia S.A. Cluj-Napoca | Risk: 32.0 | 7 |
| 9 | Marova Petfood SRL Sangeru De Padure | Risk: 75.6 | 7 |
| 10 | BOROMIR IND S.R.L. RAMNICU VALCEA | Risk: 26.0 | 6 |
| 11 | Rontis Romania Pharma Otopeni | Risk: 33.2 | 6 |
| 12 | UNILEVER ROMANIA Ploiesti | Risk: 33.0 | 6 |
| 13 | Sc Farmec Sa Cluj-napoca | Risk: 39.0 | 6 |
| 14 | CONSERVFRUCT SRL Baltatesti | Risk: 34.4 | 6 |
| 15 | S.C. Amylon S.A. Sibiu | Risk: 28.9 | 5 |
| 16 | Velcio Loana Bucharest | Risk: 39.6 | 5 |
| 17 | Risk: 34.5 | 5 | |
| 18 | Dragomir Emilian Craiova | Risk: 49.6 | 5 |
| 19 | COLUMBOVET SRL Oradea | Risk: 60.6 | 4 |
| 20 | STARSHIP ENTERPRISE SRL Bucharest | Risk: 46.7 | 3 |
Frequently Asked Questions
How many FDA import refusals are from ROMANIA?
According to FDA records, there have been 253 import refusals for products originating from ROMANIA, involving 91 firms.
What products from ROMANIA are commonly refused by the FDA?
Products from ROMANIA 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 ROMANIA are unsafe?
Not necessarily. An import refusal indicates a specific shipment appeared to violate FDA requirements at the time of inspection. Many ROMANIA 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 ROMANIA?
Our database includes FDA import refusals for ROMANIA through 8/29/2025. 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.