FDA 483 - Miami Device Solutions, LLC. - September 16, 2021

Miami Device Solutions, LLC in Miami, FL was inspected from September 13-16, 2021, and received a Form FDA 483. The inspection revealed significant deficiencies in the documentation of corrective and preventive action (CAPA) activities. Specifically, CAPA investigations lacked documented evidence for all activities, including proposed corrective actions, their implementation, evaluations, and training for procedural updates, as well as results for design verification and defined effectiveness verification.