FDA 483 - Integrated Ophthalmic Systems, Inc - December 15, 2021

Integrated Ophthalmic Systems, Inc. in Woburn, MA, was inspected by the FDA, revealing two significant issues. The firm failed to establish and implement adequate procedures for electronic Medical Device Reporting (MDR) and lacked sufficiently defined procedures for design validation, specifically regarding code reviews and defect tracking. These observations indicate deficiencies in the firm's quality system for medical device manufacturing.