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# Guangdong Bangze Medicine CGMP Violations
- URL: https://www.fdaweb.com/guangdong-bangze-medicine-cgmp-violations/
- Published: 2026-11-03T18:34:52.000Z
- Updated: 2026-11-03T18:34:52.000Z
- Author: David McFarland
- Tags: Drugs, enforcement

FDA says its review of records and products submitted by Guangdong Bangze Medicine Co., Ltd., in Guangdong Sheng, China, in response to an agency 1/20 request, determined there were significant violations of current good manufacturing practice (CGMP) regulations for finished drugs in the firm’s production of over-the-counter drug products. A 10/26 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/guangdong-bangze-medicine-co-ltd-734509-10262026?ref=fdaweb.com) says the specific CGMP violations were: 

- failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality;
- 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, and failure to conduct appropriate laboratory testing, as necessary, for each batch of drug product required to be free of objectionable microorganisms; and
- failure of the firm’s quality unit to exercise its responsibility to ensure manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

FDA recommends that Guangdong engage a qualified consultant to perform a comprehensive six-system evaluation of its entire operation for CGMP compliance, assist it in meeting CGMP requirements, and evaluate the completion and efficacy of Guangdong’s corrective and preventive actions before the company pursues resolution of its compliance status with FDA. The agency put all of the firm’s drugs and drug products offered for import into the U.S. on an 8/7 Import Alert.

Guangdong was told to address the violations without delay and ensure that appropriate resources are allocated to fully address the violations and prevent their recurrence.