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SPAIN

SPAIN

FDA import refusal data for products from SPAIN

1346
Total Firms
4,796
Total Refusals
12/22/2025
Latest Refusal

Common Violations

1191

NOT LISTED

1014

UNAPPROVED

566

NO PROCESS

539

FRNMFGREG

481

NUTRIT LBL

329

NEEDS FCE

308

NO ENGLISH

288

NO 510(K)

264

REGISTERED

10218
222

LIST INGRE

Top Firms

#Firm NameRiskRefusals
1
Sesderma, SL

Rafelbunol

Risk: 79.1189
2Risk: 80.6104
3Risk: 46.249
4
Lendan Cosmetica Tecnica

Sant Boi de Llobregat

Risk: 47.749
5Risk: 57.147
6Risk: 51.147
7Risk: 48.842
8Risk: 65.640
9Risk: 60.837
10Risk: 47.436
11Risk: 63.436
12
Fenin

Madrid

Risk: 47.436
13Risk: 57.432
14Risk: 53.431
15Risk: 39.028
16Risk: 48.628
17Risk: 62.328
18
Helios

Valladolid

Risk: 58.328
19Risk: 57.725
20
Nestle Espana

Esplugues de Llobregat

Risk: 39.325

Frequently Asked Questions

How many FDA import refusals are from SPAIN?

According to FDA records, there have been 4,796 import refusals for products originating from SPAIN, involving 1346 firms.

What products from SPAIN are commonly refused by the FDA?

Products from SPAIN 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 SPAIN are unsafe?

Not necessarily. An import refusal indicates a specific shipment appeared to violate FDA requirements at the time of inspection. Many SPAIN 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 SPAIN?

Our database includes FDA import refusals for SPAIN through 12/22/2025. 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.