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# Consultants Share Checklist for FDA Site Inspections
- URL: https://www.fdaweb.com/consultants-share-checklist-for-fda-site-inspections/
- Published: 2016-07-20T12:00:00.000Z
- Updated: 2026-09-14T21:16:12.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5136232

EG Lifesciences says that companies should have a site inspection readiness team on hand and ready to take action whenever FDA inspectors arrive for an announced or unannounced visit. Once inspectors arrive, a recent online [post](http://eglifesciences.com/blog/the-fda-is-on-site-checklist-for-fda-site-inspections?utm%5Fcontent=33324903&utm%5Fmedium=social&utm%5Fsource=twitter) says, companies should use the following checklist for key logistical considerations: 

- be sure that security has a contact list to know who to contact when an inspector arrives;
- send a company communication to alert employees when FDA is on site;
- designate a “war room” to be the center of activity during the visit and the place where the site inspection team sets up to print reports and manage documentation as needed;
- appoint “scribes” to be present in the room at all times with a notebook to take meticulous notes that capture everything the inspectors say and note the action items;
- appoint “runners” to field requests from inspectors and work with scribes to gather all requested documentation;
- have a documentation representative record all documents that the inspector wants to review and keep a record of which documents were accessed;
- appoint “escorts” to accompany inspectors and show them where things are such as restrooms and the cafeteria;
- be prepared for the “opening meeting” with a presentation on the manufacturing facility that covers all elements of the manufacturing process;
- send a site-wide notification to let employees know when the inspectors have left; and
- schedule and hold internal close-out meetings to discuss the visit and assign daily action items to be completed for the next day to expedite the process for FDA.

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