Regulations of Medicament Manufacturer Inspection Article 14
When conducting inspections, the inspector shall present proof of identity (i.e. Inspector Badge). During inspections, said personnel may ask for and make copies of relevant documents; when necessary, they may obtain samples, take photographs and make audio recordings for evidence.If the inspected party refuses, evades or interferes without reasons, the inspection may directly be determined non-compliance.
中文原文 藥物製造業者檢查辦法第14條
檢查人員執行檢查任務時，應出示身分證明文件；檢查時，得索取並影印相關文件；必要時，得取樣、照相並錄音存證。
如受檢查業者無故拒絕、規避或妨礙時，得逕予判定該次檢查結果為不合格。
如受檢查業者無故拒絕、規避或妨礙時，得逕予判定該次檢查結果為不合格。