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# CGMP Deviations at Wuhu Nuowei Chemistry
- URL: https://www.fdaweb.com/cgmp-deviations-at-wuhu-nuowei-chemistry/
- Published: 2025-02-12T12:00:00.000Z
- Updated: 2026-09-14T14:53:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158649

A 9/2-9/6/2024 FDA inspection at the Wuhu Nuowei Chemistry drug manufacturing facility in Xuancheng, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 2/4 Warning Letter says the specific deviations were:

- failure to ensure that all specifications and test procedures are scientifically sound and appropriate to ensure that the APIs conform to established standards of quality and purity;
- failure of the firm’s quality unit to exercise its responsibility to ensure the APIs manufactured at the firm’s facility comply with CGMP; and
- failure to establish adequate written procedures for cleaning equipment and its release for use in manufacturing APIs.

FDA says the inspection findings demonstrate that Wuhu does not operate an effective quality system following CGMP. The letter acknowledges the firm’s commitment to cease production of drugs for the U.S. market and that it deregistered its facility as a drug manufacturer. It asks Wuhu to indicate whether it intends to resume manufacturing for the U.S. market. FDA placed Wuhu’s products on a 1/24 Import Alert.

The company was told to promptly correct its deviations and to respond with a list of specific actions it has taken to address the deviations and prevent their recurrence, with a schedule for completing the corrections.