FDA 483 - Prestige Medical - January 13, 2023

This FDA Form 483 was issued to Prestige Medical, a medical device manufacturer in Northridge, CA, following an inspection. Observations noted deficiencies in the firm's procedures for controlling nonconforming product, including tagging, segregation, and rework. Additionally, the firm failed to adequately maintain device history records by not including primary identification labels and control numbers.