FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG - September 20, 2024
Discuss this record with AI
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.
An FDA inspection of Vetter Pharma-Fertigung GmbH & Co. KG, a drug product manufacturer, revealed significant deficiencies in aseptic processing and quality assurance. Observations included inadequate procedures to prevent microbiological contamination during sterile drug product manufacturing and a failure by Quality Assurance to provide clear conclusions on process validation data. These issues indicate a lack of control over critical manufacturing and quality systems.
ID · 36a3eb74-ac85-4c9e-a1a3-1b3247c9639d