FDA 483 - Resonance Technology Inc - October 17, 2025

Resonance Technology Inc., a medical device manufacturer in Northridge, CA, was inspected by the FDA from October 15-17, 2025. The inspection resulted in an FDA Form 483, highlighting a critical quality system observation. The primary issue identified was the company's failure to properly validate a key manufacturing process for its Class II Medical Devices, including the CinemaVision CV2020 System. The investigator noted that processes not fully verifiable by subsequent inspection and test must be validated per established procedures, specifically referencing the firm's own Process Validation SOP 75-08. Instead, Resonance Technology Inc. was found to be using a less comprehensive Workstation Verification SOP 75-13 for these processes. This observation indicates a non-conformance with the quality system requirements mandated under the Federal Food, Drug, and Cosmetic Act. Benjamin Montero, Quality Assurance Manager, received the report. The company has indicated a commitment to correcting this deficiency, and is responsible for conducting internal audits to ensure full compliance with regulatory standards.