483
Beds by GeorgeFDA 483 - Beds by George - December 02, 2021
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Record Details
Beds by George, a manufacturer of semi-electric beds, was inspected by the FDA from November 30 to December 2, 2021. The inspection revealed a significant repeat observation regarding the firm's design history file, specifically failures in design verification and validation for their medical devices. This indicates a serious lapse in quality system requirements for medical device design controls.
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ID · f993a09e-7bba-4140-aab0-69935880a00c