FDA 483 - F. Hoffmann-La Roche AG

An FDA inspection of F. Hoffmann-La Roche Ltd.'s drug substance manufacturing facility in Basel, Switzerland, identified an inadequate monitoring frequency for water used in manufacturing. Specifically, the water used directly in the process stream was not sampled frequently enough for bioburden and endotoxin at its points of use. This indicates a potential quality control issue in the manufacturing process.