FDA 483 - Oscor Inc. - September 10, 2021

Oscor Inc. in Palm Harbor, FL, a medical device manufacturer, was cited for significant deficiencies across its quality system. Observations included a failure to establish design control procedures for a Class 2 device, inadequate control of production processes related to test method validations for device packaging, and a lack of established schedules for equipment maintenance and associated documentation control. These issues indicate a systemic breakdown in quality management practices.