Warning Letter — Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd.
The FDA issued a Warning Letter to Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. following an evaluation by the Center for Drug Evaluation and Research (CDER). The letter highlights compliance deficiencies related to Current Good Manufacturing Practice (cGMP).
This affects Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd., its manufacturing and quality departments, and any pharmaceutical firms utilizing their products in their supply chains.
The issuance of a Warning Letter by CDER indicates significant deviations from cGMP standards that could impact the regulatory status of the firm's products in the U.S. market. This may lead to import alerts or the withholding of drug approvals if the firm is listed as a manufacturer in pending applications. Quality teams should monitor for potential supply chain disruptions if the facility's compliance status remains unresolved.
Conduct a comprehensive audit of Current Good Manufacturing Practice (cGMP) adherence, focusing on laboratory controls and manufacturing documentation. Review the status of international facilities within the supply chain to ensure compliance with CDER expectations prior to importation.
FDA Warning Letter issued to: Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd.. 08/06/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tianjin-kilo-pharmaceutical-sci-tech-co-ltd-731761-08062026
Open in openFDA / FDA.gov