483
Resonea, Inc.FDA 483 - Resonea, Inc. - December 09, 2022
Record Details
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.
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ID · 23132ad7-00af-4c25-9513-14c9278e1d48