FDA 483 - Liquipak Corp. - October 16, 2025

During an FDA inspection conducted from October 14-16, 2025, Liquipak Corporation, a repacker and relabeler based in Alma, MI, received a Form FDA 483 detailing significant observations. The inspection revealed several issues impacting the company's operational compliance and quality system. Key observations included a lack of a written program for routine calibration and inspection of electronic equipment; specifically, a production scale was not calibrated across its full operational range, and daily checks were not performed. Additionally, deficiencies were noted in the written procedures and practical execution of equipment cleaning and maintenance, evidenced by improperly stored cleaning hoses and damaged storage bags for clean equipment parts. Furthermore, the firm lacked established written procedures for annual product evaluations, which are required to include reviews of complaints, recalls, and investigations. The company also failed to perform annual reserve sample inspections. These observations indicate areas where Liquipak Corporation needs to implement comprehensive corrective actions to ensure adherence to regulatory requirements and maintain product quality.