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# CGMP Violations at China’s Yangzhou Sion
- URL: https://www.fdaweb.com/cgmp-violations-at-chinas-yangzhou-sion/
- Published: 2025-03-26T12:00:00.000Z
- Updated: 2026-09-14T14:56:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158892

An FDA 9/23-9/27/2024 inspection at the Yangzhou Sion Commodity Co. drug manufacturing facility in Yangzhou, Jiangsu, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/12 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/yangzhou-sion-commodity-co-ltd-699183-03122025?ref=fdaweb.com) says the specific violations were:

- failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
- failure of the quality control unit to exercise its responsibility to ensure that manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity; and
- failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards.

The letter acknowledges that the company is using a consultant to perform data integrity training. It strongly recommends that it also retain a consultant to audit its operation and assist in data integrity remediation to meet FDA requirements.

FDA placed the firm’s products on a 1/31 Import Alert. Yangzhou was told to correct violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.