FDA 483 - FRUEH VERPACKUNGSTECHNIK AG - March 24, 2023

FRUEH VERPACKUNGSTECHNIK AG, a drug product and medical device packager in Fehraltorf, Switzerland, was cited with six observations during an FDA inspection. The observations highlight significant deficiencies in cleaning validation, supplier control for bioburden, batch record documentation, quality unit oversight, lot identification, and sterilization process validation. These issues indicate a lack of robust quality systems and control over critical manufacturing and packaging processes.