FDA 483 - Bleep, LLC - August 25, 2023

Bleep, LLC, a manufacturer of the Bleep DreamPort System in Chapel Hill, NC, received a Form FDA 483 with five observations. The inspection revealed significant deficiencies in design change procedures, CAPA documentation, design plan establishment, supplier evaluation, and the organizational structure for quality system management, particularly concerning outsourced entities. These issues indicate a lack of robust quality system controls for medical device manufacturing.