FDA 483 - Active Life Scientific, Inc - June 11, 2025

An FDA inspection of Active Life Scientific, Inc. in Santa Barbara, CA, a medical device manufacturer, identified one observation related to inadequate procedures for device history records. Specifically, the firm's DHRs for the OsteoProbe System did not clearly indicate the final manufacturing date or include the device label and identifier. This indicates a moderate severity issue concerning quality system documentation for medical devices.