FDA 483 - Carl Zeiss Meditec AG (Jena) - March 07, 2024

An FDA inspection of Carl Zeiss Meditec AG (Jena), a medical device manufacturer in Jena, Germany, revealed two significant observations. The firm's device history records did not consistently demonstrate manufacturing in accordance with the device master record, specifically due to incomplete manufacturing procedures for the MEL 90. Additionally, procedures for the acceptance and control of in-process product were found to be inadequately established.