近日，FDA發布了保險套製造商岡本橡膠製品有限公司（Okamoto Rubber Products Co.）泰國工廠的警告信，FDA發現該公司的糾正措施的規程是英文版的，而沒有適用於質量體系的母語泰語版本，該規程被提交用於答覆上一次FDA檢查缺陷！
FDA還表示，該公司兩年多來一直沒有解決如何和/或為什麼未能實施更新的泰語糾正和預防措施規程的問題。此外，沒有任何更新或員工培訓的文件已提交給FDA進行審查。
缺陷翻譯如下：
The corrective actions for anObservation from the previous FDA inspection required updating your firm’sprocedure, (b)(4), Corrective Action Procedure, to include the requirement todocument the scope of the defect and the basis for determining the scope of thedefect. The current revision of (b)(4), Corrective Action Procedure, Rev(b)(4), Effective 25 Feb 17, which implements this change is only approved inEnglish and not yet approved in the native Thai language used for your firm’squality system.
前次FDA 檢查缺陷的糾正措施要求修訂貴公司的程序（b）（4）《糾正措施規程》，以包含記錄缺陷範圍的要求以及確定缺陷範圍的基礎。用於實施此要求的當前版本的（b）（4）《糾正措施規程》，版本（b）（4），自 2 月 17 日生效，僅批准了英文版，尚未以適用於你公司質量體系的母語泰語呈現。
Your firm stated that the issue occurred becausethe document was issued in English instead of Thai first, and its proceduresdid not previously contemplate whether to translate documents into Thai, onlyinto English. Your firm committed to translating its current CAPA procedureinto Thai and implementing it. Your firm committed to updating its documentcontrol procedure to only issue documents in Thai and translate into Englishwhen necessary and to train its employees. However, your firm has not committedto reviewing all other documents that are available in English to ensure theyhave been implemented in the manufacturing setting in Thai. Your firm does notaddress how and/or why it failed to implement an updated CAPA procedure in theThai language for over two years. Additionally, no documentation of any updatesor employee training has been submitted to FDA for review.
貴公司表示，之所以出現這個問題，是因為文件最早是先以英文而不是泰文發布的，而以前也沒有考慮是否將文件翻譯成泰文，只是英文形式。貴公司承諾將當前的 CAPA 程序翻譯為泰文並實施。貴公司承諾修訂《文件控制規程》，以僅籤發泰文版文件，並在必要時翻譯成英文，並培訓員工。但是，貴公司並為承諾審查所有其他可用的英文版文件，以確保這些文件已在泰文生產環境中得到實施。貴公司沒有解決如何和/或為什麼在兩年多的時間裡未能使用泰文修訂該 CAPA 程序。此外，沒有向 FDA 提交任何新的文件或員工培訓記錄以供審閱。