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CHINA

CHINA

FDA import refusal data for products from CHINA

16235
Total Firms
53,149
Total Refusals
12/31/2025
Latest Refusal

Common Violations

13354

NOT LISTED

7408

FRNMFGREG

6433

REGISTERED

5542

NO 510(K)

4715

FILTHY

3387

UNAPPROVED

2577

MELAMINE

2412

TP NO PMTA

2048

TP NO SE

1016
1797

DIRECTIONS

Frequently Asked Questions

How many FDA import refusals are from CHINA?

According to FDA records, there have been 53,149 import refusals for products originating from CHINA, involving 16235 firms.

What products from CHINA are commonly refused by the FDA?

Products from CHINA 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 CHINA are unsafe?

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

Our database includes FDA import refusals for CHINA through 12/31/2025. 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.