FDA 483 - HF Acquisition Co LLC - June 26, 2025

An FDA inspection of HF Acquisition Co LLC dba HealthFirst in Mukilteo, WA, a drug repacker and relabeler, identified deficiencies within its quality control unit. The firm failed to demonstrate adequate document control over batch record documents and utilized an uncontrolled logbook for tracking drug product returns. These observations indicate a need for improved adherence to quality system procedures.