3 replies to this topic

[KrissyK]

Does anyone have any insight as to what the FDA's initial round of IA Rule auditing will look like?  Will they be doing a deep dive or just ensuring all the parts are there and we are monitoring appropriately? 

 

Thanks!
Krissy 

[TimG]

I actually remember reading something on this on the FDA website recently.. found it in my browser history it's  https://www.fda.gov/...-acts-terrorism

Scroll down to almost the bottom and the question: 

Q: When will routine inspections begin, and what will they look like?

[SQFconsultant]

Based on their own articles the FDA plans on rolling out in March 2020 and will only be looking at parts - such as a food defense plan and others and may do these inspections at the same time as other inspections are done. It looks like they will be "playing nice guy" while at the same time they will enforse the regulations, compliance, etc.  There was even a note they night educate at the same time too.

 

My take - when the government comes knocking - be ready for anything.

[KrissyK]

Thanks to you both!  I was having a hard time finding any information on the actual audits. Just wanted to be prepared, it's all implemented but was just curious as the what the mind frame of the audit would be.