FDA 483 - VCI ACQUISITION, LLC - March 13, 2018

The FDA inspected Vital Connections, Inc., a medical device manufacturer in Tipp City, OH, from March 5-13, 2018. The inspection revealed significant deficiencies across multiple quality system areas, including a lack of process validation, inadequate design validation, insufficient process controls, and failures in corrective and preventive action procedures. Additionally, issues were noted with documentation of rework activities, document control, and device history records, indicating a systemic breakdown in quality management.