FDA 483 - ELOS MEDTECH PINOL A/S - February 07, 2019

An FDA inspection of ELOS MEDTECH PINOL A/S in Gorlose, Denmark, from February 4-7, 2019, revealed two significant observations. The firm's corrective and preventive action (CAPA) procedures were found to be inadequate, specifically concerning the dissemination of information related to quality problems. Additionally, records for acceptable contractors were not properly established, as the approved supplier list inaccurately classified a production equipment maintenance provider.