FDA Audit next week

[Doug Tropf]

We were advised by the FDA that they will be out next week to conduct an audit. I'll post on how it goes and any insights I gain on what they are focusing on.

[GStough]

Originally Posted by Doug Tropf

We were advised by the FDA that they will be out next week to conduct an audit. I'll post on how it goes and any insights I gain on what they are focusing on.

Good luck next week, Doug! Please let us know how things go.

[Aaron Lupo]

Originally Posted by Doug Tropf

We were advised by the FDA that they will be out next week to conduct an audit. I'll post on how it goes and any insights I gain on what they are focusing on.

Good luck, I would make sure your CAPA system is upto speed.

[Scott Catron]

Originally Posted by Doug Tropf

We were advised by the FDA that they will be out next week to conduct an audit. I'll post on how it goes and any insights I gain on what they are focusing on.

Since when do they let you know they're coming?

In June, I came back from a vacation on a Monday to learn the FDA had come for an inspection the previous Friday. They were just interested at looking at one part of the business - finished pharmaceuticals - and told us someone else will be coming later this year to look at our APIs. That's the first time we've ever had advanced warning of an inspection in the 10+ years I've been here.

Everything went well - no FDA-483 issued. We've had some 'interesting' history with the FDA in the past, so this was a welcome result - especially to the owners.

I'll echo Aaron on his advice - a good CAPA system is golden. They'll look for holes in your validations also - especially cleaning validations.

Good luck next week, Doug.

[GStough]

Originally Posted by Scott Catron

...Since when do they let you know they're coming? ...

In a previous life, they gave us a 24-hour notice that someone would be arriving for an inspection. I'm not sure if there is a rhyme or reason to why sometimes they give notice and sometimes they don't....

[Scott Catron]

Originally Posted by GStough

In a previous life, they gave us a 24-hour notice that someone would be arriving for an inspection. I'm not sure if there is a rhyme or reason to why sometimes they give notice and sometimes they don't....

It may depend on the district office involved.

[Doug Tropf]

Information on Pre-announcement of Inspections can be found in the FDA's Guide to Inspections of Quality Systems.

I was aware that CAPA issues have been the items most cited in recent years and have spent alot of time and effort bringing our CAPA procedures up to speed. Our registrar was OK with our CAPA system, however I believe we could do a better job with our root cause analysis efforts.

I have also reviewed some recent 483s citing complaint handling - particularly as it applies to MDR procedures. As a contract sterilizer, we don't actually market the product, so my understanding is the MDR requirements of CFR 803 would not apply to our operation.

Thanks for the good luck wishes. This is our first FDA inspection in soon to be four years.

[ScottK]

Good luck.
All my federal inspection visits (OSHA, FDA, EPA) have been surprise ones.
I hope you get a personable inspector.