FDA Issues Import Alerts for Two Chinese API Manufacturers Following Failed Inspections

The U.S. Food and Drug Administration (FDA) has placed two Chinese active pharmaceutical ingredient (API) manufacturers on import alert2.

The affected companies are Wuhu Nuowei Chemistry and Chengdu Innovation Pharmaceutical2.

Wuhu Nuowei was placed on import alert on January 24, 2025, following a four-day FDA inspection of its facility in Jingde, China2.

The import alerts were issued due to issues with the companies' quality control and testing procedures2.

An import alert allows the FDA to detain products at the U.S. border without physical examination5.

To have their products released, the companies must demonstrate that the violations cited in the import alert have been addressed5.

This action is part of the FDA's ongoing efforts to ensure the quality and safety of pharmaceutical ingredients entering the United States5.

The FDA has the authority to refuse products that appear to be in violation of FDA laws and regulations under Section 801 of the Federal Food, Drug, & Cosmetic Act5.

These import alerts highlight the continued scrutiny of foreign drug manufacturers, particularly those in China, by U.S. regulatory authorities8.

The FDA's ability to inspect and regulate foreign drug suppliers has been a topic of concern, especially in light of recent recalls of blood pressure medications8.

Sources:

2. https://endpts.com/fda-puts-two-chinese-api-makers-on-import-alert-after-failed-inspections/

5. https://www.fda.gov/industry/actions-enforcement/import-alerts

8. https://www.fiercepharma.com/manufacturing/fda-blasts-chinese-consumer-drugmaker-for-inspection-tailored-false-documents