FDA 483 - Avokaid, LLC - November 25, 2025

An FDA inspection conducted from November 18-25, 2025, identified significant quality system deficiencies at a medical device specification developer and initial importer located in Plano, TX. The inspection, detailed in a Form FDA-483, revealed six primary observations indicating a lack of established and implemented procedures crucial for regulatory compliance. Specifically, the company lacked written procedures for Medical Device Reporting (MDR), including identifying, evaluating, and timely transmitting reportable events. Complaint handling processes were also found to be inadequate, with no formal unit or established procedures for receiving, reviewing, and evaluating complaints, despite distributing Class II medical devices. Furthermore, the firm had not performed any quality audits since commencing distribution in 2023, indicating a failure to monitor quality system effectiveness. Other issues included insufficient procedures for acceptance activities, such as verifying incoming product labels, and an absence of adequately established requirements for suppliers, contractors, and consultants, particularly concerning design, development, and manufacturing partners. Finally, the firm had not defined or implemented procedures for corrective and preventive actions (CAPA), critical for addressing and preventing quality problems. The company has committed to correcting all identified observations. These issues collectively highlight a systemic lack of robust quality system controls.