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ESTONIA

ESTONIA

FDA import refusal data for products from ESTONIA

26
Total Firms
240
Total Refusals
12/18/2025
Latest Refusal

Common Violations

177

TP NO PMTA

124

TP NO SE

93

TPLKUSSLLB

18

TP FLAVOR

13

UNSAFE ADD

12

NO 510(K)

12

NOT LISTED

FRNMFGREG

8

UNAPPROVED

10249
4

FILTHY

Top Firms

#Firm NameRiskRefusals
1
NICOTECH OU

Harjumaa

Risk: 70.367
2Risk: 72.766
3Risk: 69.251
4
E-Piim

Poltsamaa

Risk: 58.713
5
Parasym OU

Tallinn

Risk: 56.57
6Risk: 48.75
7Risk: 25.84
8
NICOTECH OU

Harjumaa

Risk: 42.83
9
PARASYM O

Tallinn

Risk: 39.72
10Risk: 43.32
11Risk: 47.32
12
Wellspa

Raplamaa

Risk: 35.32
13Risk: 58.22
14Risk: 31.82
15Risk: 36.91
16Risk: 32.31
17Risk: 40.31
18
Kalev As Ltd

Eesti Vabariik

Risk: 30.31
19
FUTURE360

Tallinn

Risk: 54.61
20
Indium Top

Tallinn

Risk: 28.31

Frequently Asked Questions

How many FDA import refusals are from ESTONIA?

According to FDA records, there have been 240 import refusals for products originating from ESTONIA, involving 26 firms.

What products from ESTONIA are commonly refused by the FDA?

Products from ESTONIA 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 ESTONIA are unsafe?

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

Our database includes FDA import refusals for ESTONIA through 12/18/2025. 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.