FDA 483 - Chugai Pharmaceutical Co., Ltd. - August 30, 2019

Chugai Pharmaceutical Co., Ltd. in Fujieda, Japan was inspected from August 26-30, 2019, revealing significant deficiencies. The firm failed to thoroughly review unexplained discrepancies, leading to the release of drug batches with foreign matter and inadequate investigation into contamination sources. Additionally, the quality control unit did not ensure proper humidity storage conditions for empty capsules, potentially affecting their quality and purity.