FDA 483 - Medicalock Corporation - May 07, 2025

During an inspection conducted from May 6-7, 2025, Medicalock Corporation in Ettrick, WI, received a Form FDA 483 with one observation. The finding indicates a deficiency in the firm's quality system regarding the establishment of records for acceptable consultants, specifically failing to follow its own supplier control procedures. This suggests a need for improved adherence to internal documentation and supplier management processes.