FDA 483 - Securitas Healthcare LLC - June 22, 2023

An FDA inspection of Securitas Healthcare LLC in Lincoln, NE, a manufacturer of Class II medical devices, identified one observation. The firm's device history records for the Arial Moisture Resistant Call Station were found to be deficient. Specifically, the records did not include or refer to the location of unique device identifiers (UDI) or universal product codes (UPC).