Your firm did not retain complete raw data from testing performed to ensure the quality of your APIs. Specifically, your firm deleted all electronic raw data supporting your high performance liquid chromatography (HPLC) testing of all API products released to the U.S. market. In addition, your firm failed to retain basic chromatographic information such as injection sequence, instrument method or integration method for the tests. Your firm’s lack of data control causes us to question the reliability of your data.Oh, those old files? We don't need them! (You really wonder what happened to them -- freak backup accident?)
In addition, your laboratory management was unaware of, and therefore did not follow, the written procedure detailing the review of analytical data. Furthermore, your management confirmed that the review of analytical data did not include evaluating the system suitability parameters to ensure proper column performance.
Wednesday, July 16, 2014
Warning Letter of the Week: files schmiles backup schmackup
From the FDA, a missive to the management of Trifarma S.p.A.: