FDA 483 - MONOCENT INC. - August 19, 2021

An FDA inspection of MONOCENT INC. in Chatsworth, CA, from August 17-19, 2021, revealed a significant issue with process control procedures. The firm failed to adequately establish procedures for recording in-process non-conformities during the relabeling and repacking of medical devices. This indicates a lack of robust controls to ensure product conformance to specifications.