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SOUTH AFRICA

SOUTH AFRI

FDA import refusal data for products from SOUTH AFRICA

538
Total Firms
2,008
Total Refusals
12/12/2025
Latest Refusal

Common Violations

697

UNAPPROVED

384

NOT LISTED

335

NUTRIT LBL

313

UNSAFE COL

264

LIST INGRE

138

LACKS N/C

132

NO PROCESS

104

NEEDS FCE

98

LABELING

10274
85

COLOR LBLG

Top Firms

#Firm NameRiskRefusals
1Risk: 61.0105
2
Jonen Freight Ltd

Johannesburg

Risk: 52.068
3Risk: 46.955
4Risk: 75.353
5
Nestle

Johannesburg

Risk: 46.853
6
W. Last CC

Johannesburg

Risk: 63.049
7Risk: 49.141
8Risk: 47.736
9
Tiger Brands

Johannesburg

Risk: 63.736
10Risk: 60.033
11Risk: 56.233
12Risk: 62.927
13Risk: 44.726
14Risk: 56.326
15Risk: 68.524
16
Go2Pharma

Cape Town

Risk: 50.824
17
Organic Aloe

Albertinia

Risk: 43.322
18
Cadbury (Pty) Ltd

Port Elizabeth

Risk: 37.121
19Risk: 37.020
20Risk: 43.119

Frequently Asked Questions

How many FDA import refusals are from SOUTH AFRICA?

According to FDA records, there have been 2,008 import refusals for products originating from SOUTH AFRICA, involving 538 firms.

What products from SOUTH AFRICA are commonly refused by the FDA?

Products from SOUTH AFRICA 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 SOUTH AFRICA are unsafe?

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

Our database includes FDA import refusals for SOUTH AFRICA through 12/12/2025. 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.