ITALY
ITALY
FDA import refusal data for products from ITALY
Common Violations
Top Firms
| # | Firm Name | Risk | Refusals |
|---|---|---|---|
| 1 | F.L. Medical S.R.L. Padova | Risk: 79.7 | 372 |
| 2 | Luxottica Spa Milan | Risk: 55.5 | 200 |
| 3 | Risk: 69.9 | 136 | |
| 4 | SALVA NEW SRL Turin | Risk: 53.5 | 129 |
| 5 | Risk: 57.5 | 125 | |
| 6 | Risk: 53.3 | 124 | |
| 7 | Ciemme Alimentari S.r.l. Barletta | Risk: 68.4 | 102 |
| 8 | Istituto Ganassiini Milan | Risk: 63.0 | 98 |
| 9 | La Marchesa Soc. Coop. Agricola Teverola | Risk: 71.7 | 98 |
| 10 | Life Italia S.R.L. Cusago | Risk: 52.2 | 93 |
| 11 | Luxottica Group S.P.A. AGORDO | Risk: 61.1 | 91 |
| 12 | Rummo Lenta Lavorazione Spa Benevento | Risk: 48.0 | 75 |
| 13 | PHARMA GREEN S.R.L. Falciano | Risk: 49.1 | 72 |
| 14 | Basso Fedele & Figli S.r.L. San Michele di Serino | Risk: 66.5 | 69 |
| 15 | Campo d"Oro S.r.l. Sciacca | Risk: 61.6 | 67 |
| 16 | Beltapharm SPA Cusano Milanino | Risk: 66.0 | 62 |
| 17 | Risk: 56.9 | 62 | |
| 18 | TESA SRL Foligno | Risk: 69.0 | 61 |
| 19 | Invatec Innovative Technologies S.P.A. Roncadelle | Risk: 57.4 | 55 |
| 20 | Safilo S.P.A Padova | Risk: 49.5 | 53 |
Frequently Asked Questions
How many FDA import refusals are from ITALY?
According to FDA records, there have been 10,930 import refusals for products originating from ITALY, involving 2757 firms.
What products from ITALY are commonly refused by the FDA?
Products from ITALY 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 ITALY are unsafe?
Not necessarily. An import refusal indicates a specific shipment appeared to violate FDA requirements at the time of inspection. Many ITALY 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 ITALY?
Our database includes FDA import refusals for ITALY through 12/31/2025. 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.