Warning Letter — Guangdong Bisutang Biotechnology Co., Ltd.
The FDA issued a Warning Letter to Guangdong Bisutang Biotechnology Co., Ltd. following an evaluation by the Center for Drug Evaluation and Research (CDER). The specific regulatory violations are not detailed in the provided excerpt but are linked to current good manufacturing practice (CGMP) standards.
This notice affects Guangdong Bisutang Biotechnology Co., Ltd., as well as its quality, manufacturing, and regulatory departments responsible for products oversight in the U.S. market.
Issuance of a Warning Letter by CDER indicates that the FDA has identified significant violations of CGMP regulations at the facility. This suggests potential risks to product quality and may result in the FDA withholding approval of new applications or supplements, or potentially placing the firm on Import Alert if the violations are not remediated to the agency's satisfaction.
Review manufacturing site compliance with CGMP requirements and ensure all drug products are listed with the FDA. Conduct internal audits of international supplier sites to ensure facility registrations and product listings are current and accurate before distribution.
FDA Warning Letter issued to: Guangdong Bisutang 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/guangdong-bisutang-biotechnology-co-ltd-733939-10272026
Open in openFDA / FDA.gov