FDA Inspection

This may sound like a very dumb question...but do FDA inspection need scheduled by the manufacturer/packer? Or are these inspections set up by the FDA on a routine basis?

We have been inspected by the USDA, but I don't recall receiving an FDA audit/inspection in the last few years.

Thanks!

The FDA shows up when they want, unannounced.   

What do you make?    We see them more rarely than you'd think...

Thanks for the quick response!

We are a distributor/repacker of candies, nuts, etc. 

We also have a small confections manufacturing facility, separate from distribution. 

The FDA conducts inspections based on risk.   They have a goal of visiting a site every X years.   

In my case, they were giving sites a couple of days notice during covid.  

If what I've heard is true, they're also drastically understaffed at the moment, and that is slowing them up.  

Ah that makes sense. Thank you both for the feedback!

We had one in February and got a few days notice. However the COVID emergency declaration has been ended by the federal government - not sure if this is still the case.

We've had a couple of visits this year across various plants, sometimes they're kind enough to call us when they're headed up the street to the plant.  Almost all visits (so far as I'm aware) will be part of an investigation, either into your company or a product you're related to.  In our case, they wanted to sample and test cantaloupe as part of their ongoing look into the 2022 outbreak.  We weren't involved in any cases related to the outbreak they tracked, but now they're heavily scrutinizing cantaloupe all over just to be safe.

They'll usually bring a team, and they'll invite themselves to everything from your production lines, storage areas, employee interviews, records, you name it.  Of course, since they're already there, you can expect them to conduct an audit.  And if you're lucky, you'll never hear from them again as they're not great about sharing findings unless they find something wrong.

There are a number of changes coming to the FDA and USDA which are going to lead to much more reliance on private inspections than on government. You'll see substantially less and less FDA inspections as the wind down continues with a good possibility of elimination under the emerging reformulated government.

Less than once in 5 years?

Even the EIAO branch of FSIS does their in-depth audits about that often on top of daily inspection.

Many FDA inspected products are lower risk, but that seems like a negligently low inspection frequency.