FDA 483 - AqVida GmbH - June 03, 2022

AqVida GmbH, a sterile drug manufacturer in Dassow, Germany, was inspected by the FDA from May 26 to June 3, 2022. The inspection revealed two significant issues: a lack of procedures for visually examining reserve drug product samples annually for deterioration, and inadequate procedures to prevent microbiological contamination of sterile drug products, specifically concerning the cleanability of a cutting device.