FDA WARNING_LETTER - Hangzhou Yiqi Biotechnology Co., Ltd - June 16, 2025

The FDA issued a warning letter to Hangzhou Yiqi Biotechnology Co., Ltd. on April 15, 2026, following a review of records requested in June 2025. The review determined that the company’s manufacturing of active pharmaceutical ingredients (APIs) significantly deviated from Current Good Manufacturing Practice (CGMP) standards, rendering their products adulterated under the Federal Food, Drug, and Cosmetic Act. The main violations included a failure to validate manufacturing processes to ensure product consistency, lack of validation for analytical testing methods, and the absence of a documented stability testing program to support product expiration dates. Furthermore, the firm failed to demonstrate that the water system used in manufacturing was appropriately monitored for purity. Due to these compliance failures, the company was placed on an import alert in January 2026. To address these issues, the FDA requires the firm to submit a comprehensive remediation plan within 15 working days. This plan must include a detailed validation program, a retrospective risk assessment for distributed products, an independent evaluation of laboratory practices, and updated procedures for monitoring water quality and product stability. Continued failure to comply may result in the FDA maintaining the refusal of the company"s products into the United States market.