Regulations of Medicament Manufacturer Inspection Article 15
For deficiencies found on inspections, medicament manufacturers shall make necessary corrective actions in accordance with inspection reports or other relevant documents of the inspecting authority by the required date, and submit a corrective action report.Where the inspected party is found to be in non-compliance, has not made necessary corrective actions by the required date, or submits a corrective action report, the inspecting authority may discipline said party in accordance with relevant regulations.
中文原文 藥物製造業者檢查辦法第15條
藥物製造業者經檢查所見缺失,應依檢查機關核發之檢查報告或有關文件,於期限內改善並檢送改善報告。
執行檢查之機關得視受檢查業者之違規情節,或於受檢查業者逾期未改善或其改善報告仍有缺失時,依相關法令規定處罰。
執行檢查之機關得視受檢查業者之違規情節,或於受檢查業者逾期未改善或其改善報告仍有缺失時,依相關法令規定處罰。