FDA WARNING_LETTER - FirstCham Co., Ltd. - October 27, 2023

The FDA issued a Warning Letter to FirstCham Co., Ltd. following an inspection from October 23-27, 2023, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The Soo’Ae Hand Sanitizing Wipes product was also deemed misbranded.

Key violations include: 1. **Failure to identity test components:** The firm did not adequately test incoming raw materials like benzalkonium chloride and glycerin, nor did they validate supplier COAs. Specifically, glycerin, a high-risk component for DEG/EG contamination, was not tested per USP identity tests. 2. **Incomplete laboratory records:** Records lacked complete testing data, including methods, results comparison to specifications, critical equipment used, and compliance with testing conditions. 3. **Inadequate production and process controls:** The firm failed to validate manufacturing processes and ensure their water system was adequately designed, qualified, and monitored for drug product formulation. 4. **Inadequate Quality Control Unit (QCU) oversight:** The QCU failed to ensure CGMP compliance, lacked written procedures for process validation, equipment qualification, analytical method validation, cleaning validation, and supplier qualification, and approved an inadequate stability study.

The firm's responses to the FDA 483 were deemed inadequate, lacking sufficient detail, evidence of corrective actions, and retrospective assessments of distributed products.

The Soo’Ae Hand Sanitizing Wipes product was misbranded because