FDA 483 - Resonea, Inc. - December 09, 2022

Resonea, Inc., a medical device manufacturer in Scottsdale, AZ, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included a lack of procedures for non-conforming product control and inadequate supplier controls for contractors and consultants. Additionally, the firm failed to conduct required annual internal quality audits and management reviews of its quality system.