Ophthalmic Labs, Inc. – FDA 483, Apr 9, 2024

Ophthalmic Labs, Inc. in Milton, MA, a medical device manufacturer, received a Form FDA 483 following an inspection that revealed significant deficiencies in its quality system. The inspection cited inadequate complaint handling procedures, failure to submit required device information to the Global Unique Device Identification Database (GUDID), and a lack of established servicing procedures. These observations indicate a need for improved controls in managing device complaints, ensuring proper device identification, and maintaining service records for their (b)(4) software program.