FDA 483 - Amrex Zetron Inc - February 08, 2024

Amrex Zetron Inc, a medical device manufacturer in Paramount, CA, was cited for multiple significant quality system deficiencies during an FDA inspection. Key issues include failures related to Unique Device Identification (UDI) for their Class II muscle stimulators and ultrasound devices, inadequate device history records, and a lack of established procedures for quality audits. Additionally, the firm failed to properly process service reports as complaints, even when they described serious device malfunctions like electrocution, with some issues being repeat observations.