FDA 483 - Atos Medical Inc - December 12, 2018

Atos Medical Inc., a medical device manufacturer, received an FDA Form 483 citing significant quality system deficiencies during an inspection in New Berlin, WI. Observations included a lack of established procedures for reworking nonconforming products, inadequate documentation of corrective and preventive actions, and failure to justify not reporting correction/removal actions to the FDA. The firm also lacked documented personnel training records.