FDA 483 - Thompson Ocular Prosthetics, Inc

An FDA inspection of Thompson Ocular Prosthetics, Inc. in San Antonio, TX, a medical device manufacturer, revealed ten significant quality system deficiencies, many of which were repeat observations from a previous inspection. Key issues included failures in quality audits, corrective and preventive action procedures, complaint handling, management review, incoming product acceptance, design control, and Unique Device Identification (UDI) compliance. The firm manufactures Class I Artificial Eyes and Class II Scleral Shells and Ophthalmic Conformers.