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

Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. OPG, a biologics blood product manufacturer in Vienna, Austria, was cited for significant cGMP deficiencies during an FDA inspection. Observations included inadequate facility maintenance and pest control, ineffective employee training and deviation investigations, and unjustified material holding times. Additionally, the firm failed to properly store reference standards, verify CAPAs effectively, adequately investigate Out of Specification results for measles antibody levels, and ensure data integrity for archived records.