FDA 483 - Orient Pharma Co., Ltd. Yunlin Plant - September 07, 2022

An FDA inspection of Orient Pharma Co., Ltd in Yunlin County, Taiwan, revealed two significant observations. The firm's batch production and control records were found to be deficient, lacking complete documentation for manufacturing steps. Additionally, the facility's stability room was not maintained in a clean and sanitary condition, with dirt, water drips, and stains observed.