FDA 483 - Asteelflash Design Solutions Hamburg GmbH - May 09, 2019

Arteelflash Design Solutions Hamburg GmbH, a contract manufacturer of LED medical devices, was cited for multiple quality system deficiencies during an FDA inspection. Observations included inadequate validation of a manufacturing process, insufficient CAPA procedures lacking effectiveness verification, and failures in document control. Additionally, the firm's environmental control and employee training procedures were found to be inadequately established.