What to expect during an FDA Audit?

Hi everyone,

We have an FDA two day visit on Monday and Tuesday next week. We aren't too worried, however, be great to know if anyone else can shed some light on what exactly we can expect?

thanks

Hey,

Just had the FDA in here last week.  They are basically going to look up what your "riskiest" product is and follow it through your chain of manufacturing and distribution.  They will do a record review on day 2 and a walkthrough on day 1 and then will sit down on day 2 or 3 and give you some corrective action and advice.  They checked things like:

Pest control

allergen management

sanitation

building cleanliness

HACCP

CCP in depth review

Generally they are really good and they don't want to hurt you or the company.  You should be fine as long as you have the controls already in place.

Is the Process in UK for (?) the same as USA ??

Just curious. :smile:

@ Kate -  what do you actually make ?

What Brendan said. They will look at your "riskiest" product and look thoroughly through that products documentation. They take Sanitation very seriously as well as Allergen Management. They will give out recommendations to you. Make sure your plant is clean and no Allergen cross-contact is present! Let everyone in your plant know you will be having an FDA audit. They will ask for Food Safety plan and ask you questions about it. Don't be terrified, they are not as scary as we think they are :)

Thanks everyone.

So far as you rightly said he has carried out the site tour. 

We actually produce smoked salmon......