FDA EIR - Oxus, Inc. - October 10, 2019

An FDA surveillance inspection of Oxus, Inc., located in Auburn Hills, MI, was conducted from October 9-10, 2019. The company, which handles complaints and services Class 2 portable oxygen concentrators (specifically the discontinued Model RS-00400), received an FDA 483 with two main observations. Firstly, the inspection found that Oxus’s procedures for corrective and preventive action (CAPA) were not adequately established, as required by 21 CFR 820.100(a). Specific issues included incomplete implementation of corrective actions for human resources and complaint handling processes, and overdue verification of CAPA effectiveness without proper documentation. Additionally, the firm's quality data analysis methods, such as CAPA Meetings and a failure mode tabulation tool, lacked formal procedural definition and consistent documentation. Secondly, the firm's procedures for receiving, reviewing, and evaluating complaints were deemed inadequate, violating 21 CFR 820.198(a). Many complaints, some over a year old, remained unclosed or uninvestigated, often due to unreturned devices, without documented justification. The company's complaint procedure also narrowly defined "complaint," excluding events like refurbishment for wear-out or misuse that should be captured. Management "promised to correct" these issues and committed to providing a written response to the FDA within 15 business days. Two additional discussion items regarding device listings and Medical Device Reporting were communicated for future follow-up.