FDA Warning Letter Explorer
Drugs · Letter issue date: Oct 27, 2026

Guangdong Bisutang Biotechnology Co., Ltd.

3 extracted findings

FDA source excerpt, selected passage

This request went unanswered as did numerous follow-up requests, including a second electronic request sent on May 19, 2026, and a separate phone call to the listed U.S. Agent of record on May 27, 2026.

Findings and supporting evidence

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Findings extracted from the letter

Selected FDA passages, not the complete letter.

01
This request went unanswered as did numerous follow-up requests, including a second electronic request sent on May 19, 2026, and a separate phone call to the listed U.S. Agent of record on May 27, 2026.
02
your “XUEYI SKIN CARE” sunscreen drug product contains the cancelled color additive CI 11680 (also known as Ext. D&C Yellow No. 5***1***).
03
there appear to be discrepancies in the electronic import entry submissions for your products, specifically regarding the failure to correctly declare your drug product listing.

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