483
Asteelflash Design Solutions Hamburg GmbHAsteelflash Design Solutions Hamburg GmbH – FDA 483, May 9, 2019
Record Details
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.
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ID · b143df3a-9825-4374-86ca-4575eef5b88c
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