FDA 483 - Bing Innovations Llc - October 17, 2023

This FDA Form 483 report details severe quality system deficiencies observed at Bing Innovations Llc in Boca Raton, FL, during an inspection from October 11-17, 2023. The firm was cited for a complete lack of established procedures across multiple critical areas, including management representation, training, CAPA, complaint handling, purchasing controls, and quality audits. These findings indicate a fundamental absence of a functional quality system, posing significant risks to product quality and regulatory compliance.