> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CGMP Violations at Guangzhou Baiyunshan
- URL: https://www.fdaweb.com/cgmp-violations-at-guangzhou-baiyunshan/
- Published: 2024-08-06T12:00:00.000Z
- Updated: 2026-09-14T14:37:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157507

A 12/4-12/8/2023 FDA inspection at the Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. in Guangdong Sheng, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/1 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/guangzhou-baiyunshan-jingxiutang-pharmaceutical-co-ltd-675823-08012024?ref=fdaweb.com) says the specific violations were:

- failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to ensure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
- failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

FDA says that because the firm failed to correct repeat violations, it should engage a qualified consultant to assist it in meeting CGMP requirements.

Guangzhou was told to correct any violations promptly and to respond with a list of specific actions it has taken to address violations and prevent their recurrence, with a schedule for completing the corrections.