Vitrolife Inc. – FDA 483, Aug 19, 2021

Vitrolife Inc. in San Diego, CA, was inspected and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in equipment maintenance schedules, documentation of acceptance activities for device history records, establishment of corrective and preventive action procedures, and the lack of statistically valid sampling plans. These issues indicate a need for comprehensive improvements in the firm's quality system for manufacturing medical devices.