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# GMP Violations in YangZhou Records Review
- URL: https://www.fdaweb.com/gmp-violations-in-yangzhou-records-review/
- Published: 2024-07-16T12:00:00.000Z
- Updated: 2026-09-14T14:35:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157353

FDA says its review of records submitted by YangZhou SuXiang Medical Instrument Co., Ltd., in Yangzhou City, China, in response to an agency request, identified significant violations of current good manufacturing practice (CGMP) regulations in its manufacturing of finished drugs. A 7/8 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/yangzhou-suxiang-medical-instrument-co-ltd-686655-07082024?ref=fdaweb.com) says specific violations were:

- failure to conduct at least one test to verify the identity of each component of a drug product;
- failure to establish written procedures for production and process control designed to assure that drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess; and
- failure to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release.

The agency placed YangZhou on a 7/1 Import Alert. It says that if the firm intends to resume manufacturing drugs for the U.S. market, it should engage a qualified consultant to assist it in meeting CGMP requirements.

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.