FDA 483 - MONOPRICE INC - July 02, 2025

An FDA Form 483 was issued to an unnamed firm following an inspection conducted from June 30, 2025, to July 2, 2025. This document detailed two significant observations related to the firm's quality system for medical devices, indicating potential non-compliance with the Federal Food, Drug, and Cosmetic Act. The primary issue identified was the absence of established procedures for handling and evaluating customer complaints. Specifically, the firm lacked documented processes to systematically manage feedback concerning device performance problems, such as allegations of inaccurate blood pressure monitors. Inspectors found no records documenting the receipt, investigation, or evaluation of these alleged deficiencies. The second major observation concerned the firm's failure to develop and implement written Medical Device Reporting (MDR) procedures. This deficiency meant the company lacked a systematic approach for collecting and reviewing device-related adverse events, evaluating information to determine reportable events, submitting required reports to the FDA within specified timeframes, and maintaining accurate records of these events. The firm acknowledged both observations and "Promised to correct" the identified issues. This FDA 483 serves as an initial report of objectionable conditions, highlighting the firm's responsibility to conduct internal audits and implement comprehensive corrective actions to address all violations of quality system requirements.