In thinking about working with sites to prepare for a potential FDA audit, we reviewed several of the recent FDA warning letters which had been sent to sites after audits were conducted.
One topic that was mentioned frequently was the issue of the site’s responses and corrective action plans, and why these were deemed inadequate by the FDA. Recently, in this example, the site states that new standard operating procedures will be put into place to avoid the same errors in the future; however, the site failed to submit the revised SOPs with their response letter to the FDA, nor did they properly explain how such errors would be avoided in the future. In other recent cases, such as here and here, the FDA warning letter came after the investigator’s responses were considered to inadequately describe the site’s corrective measurements or explain how future errors would be avoided.
Furthermore, it may come as a surprise that for sites that have been previously audited for the same study or other studies, the FDA will reexamine the corrective actions posed by the site, to determine whether or not these have been followed appropriately. Depending on how well the corrective actions have been followed, a warning letter may or may not be issued. As noted here under section 1, the FDA noted the site’s previous audit in August 2008, and cited their failure to implement the corrective actions from that audit. Specifically, the warning letter states “we have concerns about whether the corrective actions that you have currently outlined will be properly implemented and executed in a manner that will prevent the recurrence of this and similar types of violations in the future.”
Have you been involved in an audit in the past? Are you aware of the corrective actions outlined in the response letter to the FDA? Finally, are you actively following those corrective actions?
Photo Credit: Peter Gene