FDA 483 - OSI Optoelectronics Inc. - October 18, 2023

OSI Optoelectronics Inc. in Hawthorne, CA, was inspected from October 11-18, 2023, and received one observation. The inspection revealed that the company failed to adequately document the results of design validation, specifically missing data sheets for DOLPHIN 2000 sensors, within its design history file. This indicates a deficiency in their design control and record-keeping practices for medical devices.