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

During an inspection conducted by the U.S. Food and Drug Administration (FDA) at OSI Optoelectronics Inc. in Hawthorne, CA, from October 11 to October 18, 2023, the company received an FDA Form 483. This document outlines inspectional observations indicating potential deviations from regulatory expectations, particularly concerning the firm's quality system requirements. The central finding highlighted that the results of design validation were not adequately documented within the design history file. Specifically, investigators reviewing a clinical validation report for a particular device noted a reference to "values for [redacted] were [redacted] recorded to a data sheet," yet the corresponding data sheets or raw data were absent. When questioned, the Vice President of Global Quality & Regulatory Affairs confirmed that while summary data and test results were available, the original engineering notebook containing these crucial raw data sheets could not be located. This represents a significant gap in the traceability and completeness of design validation records, which are essential for demonstrating a device's safety and effectiveness. Under the Federal Food, Drug, and Cosmetic Act, firms are responsible for maintaining comprehensive records to ensure compliance. OSI Optoelectronics Inc. is now required to address this observation by conducting thorough internal self-audits to identify and rectify all quality system violations. The company also has the opportunity to submit its objections or proposed corrective and preventive actions to the FDA.