FDA 483 - Ophthalmic Labs, Inc. - April 09, 2024

During an FDA inspection conducted from April 3-9, 2024, Ophthalmic Labs, Inc. received a Form FDA 483 outlining significant observations related to their medical device quality system. The company was cited for failing to adequately establish procedures for handling complaints, specifically regarding their software program. This included not investigating numerous complaints, lacking documentation for decisions not to investigate, and failing to capture unique device identifiers (UDI) or universal product codes (UPC) in complaint records as required.

Additionally, Ophthalmic Labs, Inc. did not provide essential information for their software program to the Global Unique Device Identification Database (GUDID), a critical regulatory requirement. The inspection also revealed a lack of established procedures and documented reports for servicing activities. The firm was unable to provide documented servicing procedures or service reports that included device identification, service dates, personnel, actions performed, or test data for their software program.

These observations indicate potential non-compliance with the Federal Food, Drug and Cosmetic Act and associated medical device quality system regulations. Ophthalmic Labs, Inc. is now responsible for conducting internal self-audits, implementing comprehensive corrective actions, and formally responding to the FDA to address these identified deficiencies.