FDA 483 - Holopack Verpackungstechnik GmbH - February 18, 2020

An FDA inspection of Holopack Verpackungstechnik GmbH, a drug manufacturer in Sulzbach-Laufen, Germany, revealed significant deficiencies in their sterile drug product manufacturing processes. Observations included inadequate validation of sterile processes, issues with equipment calibration and qualification, and scientifically unsound water sampling plans for bioburden testing. These findings indicate a lack of robust controls to ensure product quality and sterility.