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MALAYSIA

MALAYSIA

FDA import refusal data for products from MALAYSIA

729
Total Firms
4,035
Total Refusals
12/18/2025
Latest Refusal

Common Violations

616

NOT LISTED

569

HOLES

546

UNAPPROVED

456

FRNMFGREG

365

NO 510(K)

356

VETDRUGRES

322

NITROFURAN

89
264

SALMONELLA

258

DV QUALITY

10482
255

NUTRIT LBL

Top Firms

#Firm NameRiskRefusals
1Risk: 84.7270
2Risk: 64.1212
3Risk: 65.7150
4Risk: 69.9116
5
QL FOODS SDN. BHD.

Hutan Melintang

Risk: 89.0109
6Risk: 82.897
7
Etumax

Petaling

Risk: 75.676
8Risk: 56.474
9Risk: 62.067
10Risk: 64.151
11
Maxvue Vision Sdn Bhd

Negeri Sembilan

Risk: 62.550
12Risk: 59.950
13Risk: 46.347
14Risk: 55.947
15Risk: 73.346
16Risk: 63.443
17
HONG SAN FROZEN FOODS SDN BHD

Seberang Perai Utara

Risk: 60.142
18
Ansell Shah Alam Sdn Bhd

Selangor Darul Ehsan

Risk: 57.839
19Risk: 63.938
20Risk: 70.138

Frequently Asked Questions

How many FDA import refusals are from MALAYSIA?

According to FDA records, there have been 4,035 import refusals for products originating from MALAYSIA, involving 729 firms.

What products from MALAYSIA are commonly refused by the FDA?

Products from MALAYSIA 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 MALAYSIA are unsafe?

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

Our database includes FDA import refusals for MALAYSIA through 12/18/2025. 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.