FDA 483 - CMIC CMO USA Corporation - May 04, 2021

An FDA inspection of CMIC CMO USA Corporation in Cranbury, NJ, a pharmaceutical manufacturer, revealed two significant observations. The firm failed to establish appropriate time limits for production phases, specifically lacking in-process hold-time parameters for drug product manufacturing. Additionally, the company's electronic record system for equipment maintenance and calibration was found to be ineffective, failing to ensure trustworthiness and reliability.