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SLOVAKIA

SLOVAKIA

FDA import refusal data for products from SLOVAKIA

47
Total Firms
209
Total Refusals
5/13/2025
Latest Refusal

Common Violations

105

NO ENGLISH

34

NOT LISTED

21

NUTRIT LBL

20

UNAPPROVED

20

CSTIC LBLG

19

NO PROCESS

16

NEEDS FCE

15

REGISTERED

11

FRNMFGREG

10260
7

FALSE

Top Firms

#Firm NameRiskRefusals
1
bajer export s.r.o

Kosice - Sidlisko Kvp

Risk: 48.4102
2
Bio-Rom S.R.O.

Bratislava

Risk: 40.218
3
Dentall S.R.O.

Presovpresov

Risk: 38.412
4
Megagear Ltd.

Bratislava

Risk: 35.87
5Risk: 58.67
6Risk: 33.75
7Risk: 33.65
8
Lek Pharma.

Ljubljana

Risk: 29.04
9
I.D.C. Holding

Bratislava - Ruzinov

Risk: 40.63
10Risk: 25.73
11Risk: 41.73
12
MONDELEZ SR

Bratislava

Risk: 21.02
13
MAX SPORT, S.R.O.

Bratislava - Nove Mesto

Risk: 39.32
14
Boos Trade

Kosice - Zapad

Risk: 26.52
15
Biotika a.s.

Slovenska Lupca

Risk: 27.12
16
Spirig Eastern A S

Bratislava - Nove Mesto

Risk: 40.31
17
Krka

Slovinsko

Risk: 32.31
18Risk: 32.31
19Risk: 32.11
20Risk: 40.31

Frequently Asked Questions

How many FDA import refusals are from SLOVAKIA?

According to FDA records, there have been 209 import refusals for products originating from SLOVAKIA, involving 47 firms.

What products from SLOVAKIA are commonly refused by the FDA?

Products from SLOVAKIA 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 SLOVAKIA are unsafe?

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

Our database includes FDA import refusals for SLOVAKIA through 5/13/2025. 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.