FDA 483 - GETSCH+HILLER MEDIZINTECHNIK GmbH - July 21, 2022

An FDA inspection of GETSCH+HILLER MEDIZINTECHNIK GmbH, a medical device manufacturer in Tuttlingen-Nendingen, Germany, revealed five significant quality system deficiencies. The firm failed to adequately establish complaint handling procedures, maintain a design history file, properly identify product acceptance status, conduct internal quality audits, and set quality objectives. These observations indicate a broad lack of compliance with medical device regulations.