FDA EIR - Vetter Pharma Fertigung GmbH & Co. KG - December 12, 2014

The U.S. Food and Drug Administration (FDA) conducted a routine Good Manufacturing Practices (GMP) inspection of Vetter Pharma Fertigung GmbH & Co. KG's facility in Ravensburg, Germany, from December 10-12, 2014. This facility serves as a critical warehouse and logistics hub for sterile drugs and raw materials for drug manufacturing, performing functions such as 100% visual inspection of finished products, stability and retain sample storage, media fill incubation, and quality control sampling.

The inspection was carried out under Compliance Program 7356.002, pertaining to Drug Manufacturing Inspections. It evaluated the firm's Quality, Facilities/Equipment, Materials, and Laboratory Controls systems. A key finding of this assessment was that no violations or issues were identified. The FDA did not issue a Form FDA483 (Inspectional Observations), nor were any verbal items discussed during or after the inspection. Consequently, the inspection was classified as "No Action Indicated" (NAI). This classification signifies full compliance with regulatory requirements at the time of the inspection, meaning no immediate corrective or follow-up actions were mandated by the FDA.