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SWEDEN

SWEDEN

FDA import refusal data for products from SWEDEN

455
Total Firms
10,307
Total Refusals
1/22/2026
Latest Refusal

Common Violations

5464

TP NO PMTA

4732

TPLKUSSLLB

3687

TP NO SE

697

TPLACKFIRM

368

TPNOWRNLBL

368

NOT LISTED

183

FRNMFGREG

152

UNAPPROVED

140

TP FLAVOR

10237
132

NO PMA

Top Firms

#Firm NameRiskRefusals
1Risk: 73.42538
2Risk: 83.4933
3Risk: 68.1811
4Risk: 82.6579
5Risk: 83.9470
6Risk: 75.0431
7Risk: 77.1392
8
Skruf Snus Ab

Stockholm

Risk: 79.7384
9
YOIK AB

Gemla

Risk: 79.8292
10Risk: 80.3286
11Risk: 82.3261
12Risk: 70.5234
13
CHAINPOP AB

Goteborg

Risk: 77.9215
14
Q-Med AB

Uppsala

Risk: 79.0200
15
HELIX SWEDEN AB

Helsingborg

Risk: 76.4175
16
MICROZERO AB

Goteborg

Risk: 74.9124
17Risk: 75.797
18Risk: 72.673
19Risk: 69.870
20Risk: 73.866

Frequently Asked Questions

How many FDA import refusals are from SWEDEN?

According to FDA records, there have been 10,307 import refusals for products originating from SWEDEN, involving 455 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 1/22/2026. 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.