If I interpret your question correctly, you are asking about "total costs" and not "out of pocket" costs. I will use the last couple FDA inspections (which at my sites have been ~10 working days), as a reference. The largest cost by far is FTE hours (which also represent a large opportunity cost):
Front room personnel costs - 80 hrs x 4 people x company std costs
Back room personnel costs - 80 hrs x 5 people x company std costs
SME personnel costs - ~60 hrs @ company std costs
Document production costs - 200-300 documents x 10 pages per doc x $10/500 pages costs of paper
Some percentage of ink/toner costs - call it $100
Water/coffee/drinks - $20
By company standard costs, I mean whatever your company uses for a fully burdened employee - for instance at one company I worked for we used $165/hr fully burdened engineering FTE - your company will vary but I can guarantee finance has such a cost calculated.
For "international" inspections you may have to pay travel costs for inspectors/auditors which can add $10k-$20K. Obviously for notified bodies there is also a fee (see your contract).
Finally, depending on the inspection, they may take samples etc, which you would count at whatever your COGs for those products would be.
g-
------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
------------------------------
Original Message:
Sent: 12-Apr-2017 16:45
From: Nanette Steffenhagen
Subject: Cost of Hosting an Inspection
Hello everyone – Does anyone have information they can share on the cost of hosting an inspection? [For example, it costs $XX,000 for a 1 week inspection; list of the cost categories that are assessed.] Thank you!
Nanette Steffenhagen | Regulatory Compliance Support Manager | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | M: +1 215-429-4162