FDA 483 - Beds by George - August 15, 2019

Beds by George, a manufacturer of patient beds in Elkhart, IN, received an FDA Form 483 with eight observations during an inspection from August 12-15, 2019. The observations primarily highlight significant deficiencies in the firm's quality system, including failures in MDR reporting, complaint handling, design controls, design history files, CAPA, incoming product acceptance, purchasing controls, and quality audits. These issues indicate a broad lack of established and followed procedures for ensuring device quality and safety.