08/27/2015

A very interesting FDA Warning Letter (WL) posted to an Investigator located in San Diego, CA serves as a reminder that failure to conduct clinical investigations in accordance with the investigational plan jeopardizes subject safety and welfare, and compromises the validity and integrity of the data collected at the site.

CDER inspected the site in California in January of 2015 for which a Form FDA 483 was issued citing several instances of the investigator not following the protocol [21 CFR 312.60].

You can find the warning letter by following this link: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm458619.htm

Although the investigator submitted a response to the FDA 483 form with a corrective actions plan, the response was inadequate primarily because the interventions did not specifically address the failure and were not found to be appropriately effective and preventive. The PI only addressed ways in which future oversights might be controlled yet he did not provide corrective actions to the findings. In most warning letters it is the other way around. There was a large amount of issues that with adequate oversight would have been identified and corrective/preventive actions facilitated, or the investigator performance reported to the FDA.

This letter provides some good examples of why a response / corrective action is not adequate and can be used as a case study. What would have been an adequate investigator response here?