FDA 483 - Strata Skin Sciences, Inc. - September 30, 2021

An FDA inspection of Strata Skin Sciences, Inc., a medical device manufacturer in Carlsbad, CA, revealed two significant quality system deficiencies. The firm failed to establish procedures for valid statistical techniques in process and product control, leading to incorrect sampling during incoming inspections. Additionally, equipment maintenance schedules were not adequately established, resulting in overdue preventative maintenance.