FDA EIR - Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) - July 16, 2016

This FDA Establishment Inspection Report details a comprehensive Preapproval and Good Manufacturing Practice (GMP) inspection of Vetter Pharma-Fertigung GmbH & Co. KG in Ravensburg, Germany. The inspection was conducted from July 18, 2016, to July 26, 2016, adhering to regulatory frameworks for drug manufacturing, specifically sterile drug processes and medical device manufacturing. The focus was on sterile-filled small volume parenteral drugs and injectable delivery devices.

Investigators thoroughly reviewed critical systems, including Quality, Production, Materials, Facilities/Equipment, Packaging/Labeling, and Laboratory controls. While the inspection identified no formal violations, two discussion points were raised with management: concerns about dosing security for a specific product and the practice of accepting active pharmaceutical ingredients (APIs) prior to formal release. Importantly, no formal inspectional observations (FDA Form 483) were issued, and the inspection concluded with a "No Action Indicated" classification. Consequently, no immediate corrective actions were formally required as a result of this specific inspection.