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URUGUAY

URUGUAY

FDA import refusal data for products from URUGUAY

83
Total Firms
247
Total Refusals
12/8/2025
Latest Refusal

Common Violations

64

UNAPPROVED

50

NOT LISTED

32

NO PROCESS

31

NO ENGLISH

31

NUTRIT LBL

29

NEEDS FCE

26

NO ENGLISH

23

PESTICIDE2

20

REGISTERED

10473
19

LABELING

Top Firms

#Firm NameRiskRefusals
1Risk: 47.028
2Risk: 54.219
3Risk: 49.313
4Risk: 44.413
5Risk: 55.112
6
Carline Intl

Montevideo

Risk: 46.68
7
Rapenor S.A.

Montevideo

Risk: 34.28
8Risk: 51.46
9
Kervie S.A Zona Franc

Montevideo Urugay

Risk: 30.16
10
Kerview S.A.

Montevideo

Risk: 32.95
11
LUCEKIM S.A.

Montevideo

Risk: 27.25
12Risk: 28.05
13Risk: 49.65
14Risk: 43.84
15
Kerview Sa

Montevidourugay

Risk: 25.44
16
Roemmers S.A.

Montevideomontevideo

Risk: 50.04
17Risk: 35.34
18Risk: 59.73
19Risk: 63.33
20
Buldey Co Sa

Montevideo

Risk: 26.13

Frequently Asked Questions

How many FDA import refusals are from URUGUAY?

According to FDA records, there have been 247 import refusals for products originating from URUGUAY, involving 83 firms.

What products from URUGUAY are commonly refused by the FDA?

Products from URUGUAY 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 URUGUAY are unsafe?

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

Our database includes FDA import refusals for URUGUAY through 12/8/2025. 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.