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AUSTRALIA

AUSTRALIA

FDA import refusal data for products from AUSTRALIA

813
Total Firms
3,178
Total Refusals
12/16/2025
Latest Refusal

Common Violations

616

COSM COLOR

527

NOT LISTED

398

UNAPPROVED

305

NUTRIT LBL

295

UNSAFE COL

194

COSMETFPLA

186

FRNMFGREG

150

REGISTERED

147

LIST INGRE

1072
129

NEW VET DR

Top Firms

#Firm NameRiskRefusals
1Risk: 88.6862
2
ONE Group

Ashmore

Risk: 48.674
3Risk: 66.874
4
Arnott's Biscuits

North Strathfield

Risk: 60.357
5
Nestles

New South Whales

Risk: 54.257
6Risk: 66.244
7
CARBON COCO

Thomastown

Risk: 44.235
8Risk: 63.033
9Risk: 63.930
10
Vetafarm Pty Ltd

Wagga Wagga

Risk: 50.130
11Risk: 43.727
12Risk: 57.524
13Risk: 54.521
14
Ding The Recipe

Seven Hills

Risk: 56.720
15Risk: 56.719
16Risk: 33.319
17Risk: 62.318
18Risk: 47.916
19Risk: 37.616
20Risk: 63.415

Frequently Asked Questions

How many FDA import refusals are from AUSTRALIA?

According to FDA records, there have been 3,178 import refusals for products originating from AUSTRALIA, involving 813 firms.

What products from AUSTRALIA are commonly refused by the FDA?

Products from AUSTRALIA 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 AUSTRALIA are unsafe?

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

Our database includes FDA import refusals for AUSTRALIA through 12/16/2025. 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.