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

SLOPE.IO, INC. was subject to an FDA inspection from April 15-18, 2024, which identified seven significant observations on Form FDA-483. The findings reveal a widespread lack of established and implemented quality system procedures, critical for regulatory compliance as a manufacturer. Specifically, the company failed to define, document, and implement essential controls across several areas.

Key violations include the absence of documented procedures for environmental control, leading to unaddressed temperature excursions impacting product inventory. The firm also lacked foundational procedures for managing customer complaints and controlling products that do not meet specified requirements, with these crucial systems reportedly not established since 2021. Additionally, there were inadequate validation activities for their inventory management software, and finished device acceptance procedures were deficient, failing to adequately inspect kit contents.

The inspection also cited a lack of consistent management reviews from 2021-2023, indicating an absence of formal oversight. Furthermore, the company lacked adequate procedures for training and maintaining comprehensive training records for employees performing various critical job functions. SLOPE.IO, INC. has acknowledged these observations and committed to implementing the necessary corrective actions to address each identified deficiency.