FDA 483 - Viant AS&O Holdings, LLC - October 28, 2024

An FDA inspection of Viant AS&O Holdings, LLC in Brimfield, MA, identified deficiencies in their medical device manufacturing processes. The firm failed to adequately establish procedures for ensuring purchased products and services conform to requirements, including the use of unverified material in Class III medical devices. Additionally, procedures for accepting incoming products were not properly established, with a lack of documented equipment verification checks and outdated procedures.