FDA 483 - OxiWear Inc. - July 30, 2025

An FDA inspection was conducted on July 29-30, 2025, at a medical device manufacturer in Buffalo, NY, identified through the CEO, Shavini E. Fernando. The inspection resulted in the issuance of an FDA Form 483, indicating observations of objectionable conditions. The primary issue cited was that design input requirements for the OxiWear OxiV3 Ear-Wearable Continuous SpO2 Data Collection System were not adequately documented. Specifically, despite the device being intended for use with patients of all skin types, the firm had not documented specific design input requirements addressing its functionality across various different skin tones. This observation, issued pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, requires the firm to conduct internal self-audits and implement corrective actions. The CEO verbally committed to correcting the identified observation, highlighting the firm's responsibility to ensure its quality system meets regulatory standards.