Drugs

CGMP Violations at Guangzhou Baiyunshan

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 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.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome