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The FDA is On-Site! Checklist for FDA Site Inspections

By Stephen Fochios
Jul 19, 2016 4:30:00 PM


In my recent blog post entitled Prepping for a Successful FDA Inspection, we discussed the importance of having a Site Inspection Readiness Team on hand that is always “at the ready” for FDA visits, regardless of whether the visits are scheduled or unannounced. But what happens once the inspectors arrive? You should have a checklist on-hand for the key logistical considerations.

While some of these roles and tasks may seem simple at the outset, each one is critical to ensure a smooth visit and will enhance your ability to follow up:

  1. Make sure that security has a contact list so that they know who to contact when the inspector shows up either pre-announced or unannounced.
  2. Send a company communication to alert employees when the FDA is on site.
  3. Designate a “war room” that will serve as the epicenter of activity during the visit. The site inspection team should set up in the war room so that they can print out reports and manage documentation as needed.
  4. Appoint “scribes.” These are the people who must be present in the room at all times with a notebook. The scribes must take meticulous notes to capture everything that the inspectors are saying and call out the action items. Remember that no audio, video or photo recordings are allowed during an on-site FDA visit.
  5. Appoint “runners.” The runner’s job is the field requests from the inspectors. The runner(s) and the scribe(s) work together to gather all requested documentation.
  6. A documentation representative should record all documents that the inspector wants to review and keep a record of which documents were accessed. This typically includes the procedures that manufacturing uses to perform daily activities.
  7. Appoint “escorts.” Keep in mind that the inspectors should not walk around your facilities unaccompanied. Escorts can show them where things are – the restrooms, cafeteria, etc.
  8. Be prepared for the “opening meeting.” Prepare your presentation of the manufacturing facility that covers all elements of the entire manufacturing process.
  9. Send a site-wide notification to let employees know when the inspector(s) have left.
  10. Schedule and conduct in internal “close out meeting” with the team to discuss the visit. Daily action items should be assigned during these meetings, and with preparation/completion of these action items for the next day, the process is expedited for the FDA.

To ensure that the visit goes smoothly and to meet all requirements, be sure that your staff is thoroughly trained on all procedures. And remind all employees to dress professionally and to keep all communication with inspectors factual and to the point.

Do you have any questions about preparing for or engaging with the FDA during site visits? We would be happy to answer them: [email protected].


Stephen Fochios

Written by Stephen Fochios LinkedIn

Stephen Fochios serves as a Principal Consultant for EG Life Sciences. He received his Bachelor’s degree in Biology from the University of Massachusetts at Amherst and has a Master’s degree in Medical Sciences and an MBA in Health Sector management and Finance from Boston University.

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