FDA 483 - Dynavision Global Holdings LLC - August 31, 2023

Dynavision Global Holdings LLC, a medical device manufacturer in Cincinnati, OH, was inspected by the FDA, revealing significant quality system deficiencies. The firm failed to adequately establish or implement procedures for corrective and preventive actions, complaint handling, nonconforming product control, and supplier management. Additionally, design verification results for the Dynavision D2 device were not properly documented in the design history file.