483
AqVida GmbHAqVida GmbH – FDA 483, Jun 3, 2022
Record Details
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.
View Company Profile
ID · cf26f43e-77a1-4732-8db4-d5924b1f6b3e
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.