Warning Letter — Shantou Qiwei Industry Co., LTD
The FDA issued a Warning Letter to Shantou Qiwei Industry Co., LTD following an evaluation by the Center for Drug Evaluation and Research (CDER).
This affects Shantou Qiwei Industry Co., LTD, specifically their personnel involved in drug manufacturing, quality control, and regulatory compliance.
The issuance of a Warning Letter by CDER indicates significant deviations from CGMP requirements. This action suggests that the facility's manufacturing processes or quality systems may be insufficient to ensure product safety and quality, potentially leading to import alerts or administrative actions if deficiencies are not addressed.
Impacted firms should conduct a comprehensive audit of Current Good Manufacturing Practice (CGMP) compliance and prepare for potential import restrictions if the violations cited in the warning letter are not remediated within the FDA's specified timeframe. Internal teams should review documentation for data integrity and process validation.
FDA Warning Letter issued to: Shantou Qiwei Industry Co., LTD. 06/02/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shantou-qiwei-industry-co-ltd-721753-06022026
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