Warning letterPosted May 19, 2026

FDA warning letter to Hangzhou Yiqi Biotechnology Co., Ltd

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

FDA's record ↗

FDA posted a warning letter to Hangzhou Yiqi Biotechnology Co., Ltd on May 19, 2026; the letter is dated April 15, 2026. Subject: CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Issuing office: Center for Drug Evaluation and Research (CDER).

On the record

Company
Hangzhou Yiqi Biotechnology Co., Ltd
Subject
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Issuing office
Center for Drug Evaluation and Research (CDER)
Letter dated
2026-04-15
Posted by FDA
2026-05-19
Source
FDA warning letters ↗

The full record

An account shows the violations FDA described and each CFR section it cited.

What a warning letter is

A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.

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