FDA 483 - Candela Corporation - January 24, 2023

Candela Corporation, a medical device manufacturer in Marlborough, MA, was inspected and cited for significant issues across three observations. The inspection revealed inadequacies in complaint file maintenance, a failure to submit a required Medical Device Report (MDR) for a malfunctioning laser, and poorly maintained device history records with illegible safety labeling. These findings indicate a moderate level of severity regarding quality system compliance.