Warning Letter — Guangzhou Jiugong Research And Development Biotechnology Co., Ltd.
The FDA issued a Warning Letter to Guangzhou Jiugong Research And Development Biotechnology Co., Ltd. following an evaluation by the Center for Drug Evaluation and Research (CDER).
This notice affects Guangzhou Jiugong Research And Development Biotechnology Co., Ltd., its manufacturing partners, and internal regulatory and quality departments responsible for drug production compliance.
The issuance of a Warning Letter by CDER typically indicates significant deviations from Current Good Manufacturing Practice (CGMP). This suggests potential risks to product quality or safety, and may lead to import alerts or restrictions on the distribution of products in the U.S. market until the violations are remediated.
Ensure all contract manufacturing organizations (CMOs) maintain strict adherence to CGMP; conduct internal audits of manufacturing sites to verify that documentation and production processes meet Center for Drug Evaluation and Research standards.
FDA Warning Letter issued to: Guangzhou Jiugong Research And Development Biotechnology Co., Ltd.. 10/27/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/guangzhou-jiugong-research-and-development-biotechnology-co-ltd-737769-10272026
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