Company: Shanghai Medical Ltd.
Product: Active pharmaceutical ingredients
Date: 2/10/04
One of the discussion points with management concerned missing data for the analysis of [redacted] and [redacted] by [redacted] There were six entries in the [redacted] logbook that could not be found in the correlating computer files.
The investigative team was together during the interaction with the above mentioned individuals regarding the test records for [_____] testing. Both give the same account of what happened. They have documented a detailed description of who they spoke with and what responses they received. None of the responses from the above mentioned individuals was accurate until the investigative team found the test results on the [_____] computer. All of the above mentioned individuals initially denied that the firm has ever tested [_____] for [_____] by [_____] Then, the QC manager said that they had done the test once a long time ago, but did not have record of the test. Later, when the investigative team looked at the [redacted] computer files, they found that [_____] testing for [_____] was routinely performed. In addition, the QC Manager denied having a written test method for [redacted] testing for [redacted] by [redacted] but the written test method was later found locked in her office desk. Lastly, when asked why the testing was performed, both the QC Manager and the Assistant Plant Manager both stated that the test was done for no reason. When the investigative team spoke with you and your management team the following day (10/30/2003) they say that you told them the testing was done at a customer’s request. The investigative team also said that you admitted that your firm had been untruthful about the testing. As the investigative team expressed to you that they did not have confidence in the integrity of your test data as a result of this incident, so we also express our concern that your test records may be unreliable.
Issuer: Center for Drug Evaluation and Research (CDER)
