FDA 483 - ACI Medical LLC - August 17, 2023

ACI Medical LLC, a Class II medical device manufacturer in San Marcos, CA, was inspected by the FDA. The inspection revealed two significant quality system deficiencies related to the maintenance of device records. Specifically, the firm failed to maintain a complete device master record with adequate soldering procedures and did not include unique device identifiers in its device history records for ArtAssist devices.