FDA 483 - Retivue Llc - April 17, 2024

This FDA Form 483 details significant quality system deficiencies at Retivue Llc in Charlottesville, VA, following an inspection from April 8-17, 2024. The firm failed to conduct management reviews and internal quality audits, and its procedures for corrective and preventive actions, supplier evaluations, and incoming product acceptance were found to be inadequate or not followed. These observations indicate a broad lack of control over critical quality processes.