FDA 483 - Center For Ocular Prosthetics, LLC - March 07, 2022

This FDA Form 483 was issued to Center For Ocular Prosthetics, LLC in Portland, OR, following an inspection from March 4-7, 2022. The inspection revealed significant deficiencies across multiple quality system areas, indicating a lack of fundamental procedures for complaint handling, corrective actions, medical device reporting, and record keeping. The firm failed to establish and implement essential quality system procedures for its ocular prosthesis devices.