483
Atos Medical IncFDA 483 - Atos Medical Inc - December 12, 2018
Record Details
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.
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ID · 6fe49d3e-0ecf-4bba-b18a-f179f733276c