Inspection Tip – Please Don’t Put the FDA Investigator in the Boiler Room

Inspection Tip – Please Don’t Put the FDA Investigator in the Boiler Room

March 14th, 2013 // 3:43 am @

March 14, 2013

 The $100,000 FDA Compliance Disaster

Please don’t do this to your FDA investigator.

Every time I have Dennis Moore for one of his excellent FDA inspection webinars, I marvel at some of the mistakes that some really bright folks make in the pharmaceutical industry during an inspection.It’s interesting how some of the most simple mistakes can be made during an inspection that can make a 483 or FDA warning letter much more likely.

One of the things Dennis pointed out in his Webinar yesterday (rebooked for April), is that it is very important to make the investigator comfortable during his or her inspection. This means that you need to provide the FDAer with a nice work space. Perhaps a conference room with comfortable chairs, good light and good Internet would be the best choice.

What you should NOT do, Moore said, is to put the investigator in the boiler room or some other nasty dump in your building.

How would you feel if you were stuck in the boiler room with no Internet, no A/C and bad light? It might make you a bit testy. Sure, this seems obvious, but as Dennis always points out, he saw companies make this sort of mistake a lot when he was an FDA investigator.

Other interesting tidbits from the webinar –

Also, it is recommended that during an investigation, you should have a good quality person guiding the FDAer around the site. You also should have a scribe with a laptop who is recording everything that is said. Make sure that the scribe types fast and well, and do NOT make the scribe and the guide the same person.This will lead to big problems in terms of time management for all parties, and it will put you in a bad light.

Next, when you have your ‘runner’ go and fetch files that the investigator wants, PLEASE – make sure that the runner knows where everything is! You really can’t do much worse than to have the investigator ask for a complaint file and you can’t find it. If you look sloppy and disorganized during the inspection, it will certainly make the FDAer wonder what else you are sloppy about….

And by the way, about that 15 days to respond to an FDA 483? FDA is serious.





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