FDA 483 - SLOPE.IO, INC. - April 18, 2024

SLOPE.IO, INC. in Glen Allen, VA, a medical device manufacturer, received an FDA Form 483 following an inspection from April 15-18, 2024. The inspection revealed significant and systemic deficiencies in the firm's quality system, primarily due to a lack of established and documented procedures across multiple critical areas. These issues indicate a fundamental failure to implement basic quality management practices, with many procedures not established since 2021.