FDA audits in the UK

Hi all.  We have been informed by the USFDA that they intend to audit a number of our sites here in the UK.  We export product to the US so I am guessing that this is in connection with the Food Safety Modernisation Act.  It appears to be members of the FDA that will be auditing so in preparation I have been trying to understand the standard that the FDA are expecting so we can gap assess against it.  We currently have BRC accreditation but I am finding it very difficult to find a single document that defines the FDA requirements. Does anyone have any suggestions?

Sorry to lament but I'm in the same boat.  I don't believe however, that many of the FSMA requirements come in until next year.  Please someone correct me if I'm wrong?  I am getting one of my HACCP plans HARP-C compliant though before they come so hopefully they can see I'm considering it.

Hi steverogers,

Our facility had been US FDA inspected on 2014, per my understanding they do not care what is certificate you have. They are following US FDA guidelines and regulations. You can find properly documents on the website: http://www.fda.gov/F...on/default.htm 

Good luck!

Hi steverogers -

SmallMilk is correct, FDA is going to audit your facilities based on the portions of the FSMA regulations that are in force at the time of your audit. For some reason, I got a blank web page using SmallMilk's link. The one below will take you to the FDA Food tab on their website. Type 'FSMA' into the search bar and get ready for sensory overload (may have to copy & paste).

http://www.fda.gov/Food/default.htm

KTS