FDA は、2008 年 10 月 31 日付の貴社回答書に述べられた是正措置の実施に対する貴殿の関与(コミ ットメント)に感謝している。この回答書は、貴社の品質管理部門、製造規範、分析方法、製造行為 の文書化およびラボの機器の校正に関わる手順の是正を含むものである。
In addition, we have also received your letter dated February 16, 2009, in which you provided a progress report to your previously proposed corrective actions. You indicated that you have implemented procedures, established written calibration programs, and are in the process of re-qualifying instruments. However, the procedures were not included in your response and you did not provide an assessment of the products on the market that were tested using improperly validated methods and unqualified equipment.