FDA 483 - Octapharma Produktionsgesellschaft Deutschland mbH

Octapharma Produktionsgesellschaft Deutschland mbH, a drug substance manufacturer in Springe, Germany, was cited for significant deficiencies in its quality systems. Observations included failures in batch release testing, inadequate deviation and CAPA procedures, insufficient environmental monitoring, and an inadequate cleaning validation program. These issues indicate a lack of robust controls over manufacturing processes and product quality.