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BELGIUM

BELGIUM

FDA import refusal data for products from BELGIUM

468
Total Firms
1,544
Total Refusals
12/17/2025
Latest Refusal

Common Violations

507

NOT LISTED

371

UNAPPROVED

170

REGISTERED

140

FRNMFGREG

125

NUTRIT LBL

102

NEW VET DR

100

LIST INGRE

95

UNSAFE COL

70

DIRECTIONS

10508
66

NO 510(K)

Top Firms

#Firm NameRiskRefusals
1Risk: 47.492
2Risk: 54.179
3Risk: 51.052
4
Purna Pharmaceuticals NV

Puurs-Sint-Amands

Risk: 67.532
5Risk: 41.931
6Risk: 67.330
7Risk: 69.029
8
Organon Heist

Heist-Op-Den-Berg

Risk: 72.328
9Risk: 46.127
10Risk: 46.127
11Risk: 43.426
12Risk: 50.825
13
Novartis Manufacturing NV

Puurs-Sint-Amands

Risk: 60.923
14Risk: 60.421
15
U N D A

Brussel

Risk: 40.720
16Risk: 43.219
17
Chocdecor

Lokeren

Risk: 48.317
18Risk: 39.116
19
Cardionics SA

Sint-Jans-Molenbeek

Risk: 38.716
20
Wolfs

Antwerp

Risk: 56.715

Frequently Asked Questions

How many FDA import refusals are from BELGIUM?

According to FDA records, there have been 1,544 import refusals for products originating from BELGIUM, involving 468 firms.

What products from BELGIUM are commonly refused by the FDA?

Products from BELGIUM 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 BELGIUM are unsafe?

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

Our database includes FDA import refusals for BELGIUM through 12/17/2025. 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.