07/01/2015

A very interesting FDA Warning Letter (WL) has been posted to an Investigator located in France.

CDER inspected the site in France in September of 2014. You can find the WL by following this link: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm452031.htm

The investigator was cited for several instances of not following the protocol [21 CFR 312.60].

The response to the Form FDA 483 was inadequate related to the corrective actions to include ensuring the interventions were effective and preventive. It appeared that the PI stated that the root cause of the compliance issues was mainly the fault of the patients . . . This usually does not hold up as an adequate response. This is an example of where root cause was not taken deep enough. This is likely not the primary cause and the only root cause(s).

As an industry we are focusing a lot on RBM and eIC's, etc. Balancing that with good old effective CAPA is critical. I cannot tell if there was adequate monitoring, but there was a large amount of issues that with adequate oversight this would be identified and corrective/preventive actions facilitated, or the investigator performance reported to the FDA.

Enjoy reading! Some good examples of why a response / corrective action is not adequate and used as a case study. What would have been an adequate investigator response here?