Warning letter issued to South Korea - from process validation to analysis of starting and raw materials

The FDA issued a Warning Letter to FirstCham Co, Ltd., citing violations of CGMP guidelines found during an October 2023 inspection. Key findings include:

• Failure to verify component identity and supplier analyses' reliability, notably for glycerine contamination with DEG and EG.
• Inadequate laboratory documentation lacking essential data for compliance.
• Absence of proper validation for manufacturing processes and water systems.
• Quality control deficiencies, such as lacking procedures for process validation and supplier qualification.
• Misleading labeling of "Soo'Ae Hand Sanitizing Wipes" falsely implying FDA endorsement.

To address these, the FDA mandates corrective actions, including risk assessments, process and water system validations, and quality assurance reviews. FirstCham Co., Ltd. is placed on Import Alert 66-40, allowing import detention until CGMP compliance is demonstrated.