In order to avoid a 483 and possibly an FDA warning letter, you must be prepared for a site inspection from FDA.  Following the 5 essential tips below will help you and your site prepare for, and successfully pass, an FDA audit:

    1. Assume you WILL be audited. By keeping this mindset, whether you receive a call from the FDA or not, you will have better prepared yourself and your staff for your FDA filing at the end of the study.  In 2010, the FDA’s bioresearch monitoring programs inspected 400 Clinical Investigator’s.
    2. Always Be Prepared.You and your staff should know exactly what to do from the moment the auditor calls to schedule the audit, to the moment he/she leaves the close-out visit.  I have included a few reminders below:
      • Have a plan relating to how the person who answers the phone should handle the call.  He/She should know your availability, ask what study the auditor is inspecting, and find a mutually convenient time to schedule the meeting.  Regardless of when the auditors come, you must allow them access to your site and files.
      • When the Inspector walks in the door, verify credentials and make sure he/she completes a Notice of Inspection (FDA Form 482) for you and your staff.
      • Have a point person in the office who will stay with the auditor at all times.  This person will be responsible for everything the auditor reviews.  Remember to keep a copy of everything he/she copies for themselves.
      • Respond to all requests as quickly as possible.  This is easier to do if you are very familiar with your regulatory binders and study documentation, and have full knowledge surrounding all of your sites’ Severe Adverse Events (SAEs) and their outcomes.
      • Remember if you follow your site’s SOPs, nationally recognized Good Clinical Practices, and the sponsor’s protocol then your site will be well positioned to successfully pass an FDA audit.
    3. Prepare your Standard Operating Procedures (SOPs) NOW.  Auditors will often ask for your SOPs and verify you have been following them throughout the study.  They are very important to have and are even more important to follow.
    4. Organize and maintain chronological order of documentation at all times. Stay on top of your regulatory paperwork, keep all documentation in chronological order, and stay up-to-date on printing and filing your site correspondence.  This will keep you more organized and ensure you will be better prepared for an audit.
    5. Mock FDA Inspection. It is very helpful to hire a third party company, like MCRA, to perform a mock inspection at your site.  By doing this you can discover the areas you need improvement on and fix them prior to an actual inspection.

For useful insider tips please visit the FDA’s Inspection Reference, Guides and Field Activities website.

Abigail can be reached at aallen@mcra.com.