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SWEDEN

SWEDEN

FDA import refusal data for products from SWEDEN

452
Total Firms
10,146
Total Refusals
12/31/2025
Latest Refusal

Common Violations

5344

TP NO PMTA

4701

TPLKUSSLLB

3576

TP NO SE

668

TPLACKFIRM

368

TPNOWRNLBL

364

NOT LISTED

179

FRNMFGREG

152

UNAPPROVED

140

TP FLAVOR

10237
131

NO PMA

Top Firms

#Firm NameRiskRefusals
1Risk: 73.52510
2Risk: 83.5931
3Risk: 68.4811
4Risk: 82.5561
5Risk: 84.2470
6Risk: 75.0428
7Risk: 77.4392
8
Skruf Snus Ab

Stockholm

Risk: 79.3382
9
YOIK AB

Gemla

Risk: 79.6282
10Risk: 79.8272
11Risk: 82.2260
12Risk: 70.8234
13
CHAINPOP AB

Goteborg

Risk: 77.6205
14
Q-Med AB

Uppsala

Risk: 79.3200
15
HELIX SWEDEN AB

Helsingborg

Risk: 75.5153
16
MICROZERO AB

Goteborg

Risk: 74.8123
17Risk: 74.679
18Risk: 70.070
19Risk: 73.565
20Risk: 66.963

Frequently Asked Questions

How many FDA import refusals are from SWEDEN?

According to FDA records, there have been 10,146 import refusals for products originating from SWEDEN, involving 452 firms.

What products from SWEDEN are commonly refused by the FDA?

Products from SWEDEN 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 SWEDEN are unsafe?

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

Our database includes FDA import refusals for SWEDEN 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.