Warning Letter — Hangzhou Yiqi Biotechnology Co., Ltd
The FDA issued a Warning Letter to Hangzhou Yiqi Biotechnology Co., Ltd. through the Center for Drug Evaluation and Research following an inspection or review of the firm's operations.
This action affects Hangzhou Yiqi Biotechnology Co., Ltd., its management, and personnel involved in drug manufacturing, quality control, and regulatory compliance.
The issuance of a Warning Letter by CDER suggests that the firm's manufacturing practices failed to meet Current Good Manufacturing Practice (CGMP) standards. This indicates potential risks to product quality and may result in the FDA withholding approval of new applications or prohibiting the entry of products into the United States until the deficiencies are remediated.
Review existing drug manufacturing protocols against CGMP standards and ensure all facility registrations with CDER are current. Verify that documentation for all production processes is complete and available for inspection.
FDA Warning Letter issued to: Hangzhou Yiqi Biotechnology Co., Ltd. 04/15/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hangzhou-yiqi-biotechnology-co-ltd-720707-04152026
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