FDA 483 - CSL Behring L.L.C. - May 13, 2019

CSL Behring LLC in Bradley, IL, was cited for significant deficiencies in its aseptic processing and manufacturing controls. The inspection revealed inadequate validation of aseptic processes, including multiple media fill failures, and a lack of established procedures for preventing microbiological contamination. Further issues included insufficient environmental monitoring, unestablished time limits for production phases, poorly maintained equipment, and general facility maintenance problems.