FDA 483 - Pd Products Llc - January 30, 2025

PD Products Llc in West Hills, CA, was issued a Form FDA 483 following an inspection from January 28-30, 2025. The inspection revealed significant deficiencies in the firm's quality system, specifically the complete absence of established procedures for handling complaints and medical device reporting for their Class II medical devices. These findings indicate fundamental gaps in the firm's regulatory compliance and quality management.