FDA 483 - Vivorte, Inc. - November 23, 2021

Vivorte, Inc. in Louisville, KY, a manufacturer of medical devices, received a Form FDA-483 for several deficiencies related to its quality system. Observations included inadequate documentation of sterilization process monitoring and control, distribution of products prior to completion of required tests, and insufficient documentation of corrective and preventive actions. The firm also lacked adequate sampling procedures for sterile devices and failed to maintain records for product correction or removal actions.