FDA 483 - Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.

This 483 report details significant deficiencies observed at Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. OPG in Vienna, Austria, a biologics blood product manufacturer. The inspection revealed issues across multiple areas including inadequate facility maintenance, ineffective employee training, unjustified deviations from production and QC procedures, and failures in CAPA effectiveness and OOS investigations. These findings indicate a lack of robust control over cGMP processes and data integrity.