FDA 483 - MANDELAY KFT - October 17, 2019

MANEKLAY KFT, a medical device manufacturer in Tokol, Hungary, was cited with four observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality system, including inadequate design control for their Quest9 device, insufficient complaint handling procedures, and a lack of established environmental control procedures for electrostatic discharge. Additionally, the firm failed to maintain complete Device History Records for device labeling.