FDA foreign inspection and COVID19

ugecha

Involved In Discussions
Hello, eveyone.

We are a foreign medical device manufacturer in Japan.
And we are having a foreign inspection from US FDA in two months.
Would somebody give me some advice to my questions below?
Thank you very much in advance.

My questions are

1. Our COVID19 policy should be informed in advance?
My company has a COVID19 policy which is applied to our employees as well as all visitors including an FDA inspector.
Should we tell the FDA inspector about our COVID19 policy and ask him or her to follow our rules?
For example, our policy says that we wear a face mask all the time except during meal time, eat meal with no conversation and check body temperature when to enter the building.
Does FDA consider such requests are an act of avoiding inspections?

2. What if our staff are found infected with Covid during the inspection?
Should we tell the inspector about it and ask him stop the inspection?

Thank you.
 

Sidney Vianna

Post Responsibly
Leader
Admin
Does FDA consider such requests are an act of avoiding inspections?
A reasonable inspector would abide by your reasonable expectations

What if our staff are found infected with Covid during the inspection?
Should we tell the inspector about it and ask him stop the inspection?
You should tell him, but if you unilaterally decide to stop the inspection there could be consequences.
 

Zero_yield

"You can observe a lot by just watching."
I haven't run into any inspectors from the FDA or any other organization who tried to fight COVID protocols.

FDA inspectors should be used to following posted garbing requirements nd safety protocols of any environment they're stepping into.
 

ChrisM

Quite Involved in Discussions
I would say that it is only polite to inform the FDA about any precautions that need to be taken by any visitor to the site as soon as they contact you with details/dates of their visit. I have worked at several places (in the UK) since covid started here and we have always warned any visitor as soon as we can - even if it was only to tell them that they would need to wear a face mask and take a covid test on arrival then wait outside the building for 30 minutes until the test result was known. In the case of maintenance companies they had to allow this extra time into their visit time. Not one company or person objected, I think they were all grateful for the steps we were taking.
This is not a way of avoiding inspections but a risk-control measure designed to reduce the chance of a covid infection and spread/outbreak at your premises.

If a case is discovered during the FDA inspection, the starting point is what your existing control procedures say. If you have determined that any case will result in the immediate closure of the site until a decontamination exercise has been carried out (eg wipe all surfaces, spray bacteria killer everywhere) then the FDA should be informed in advance, and also the inspector(s) informed on arrival for the visit.

Again, it is not a way of avoiding an inspection but of controlling/containing a very nasty virus that has spread globally.

In my current role, we are subjected to several independent audits/assessments to maintain product approvals and many of those external organisations have still not re-started in-person visits, relying on video links and "virtual visits"
 

ugecha

Involved In Discussions
Thank you everyone for the great advice. We will politely inform our inspector of my company's rules to prevent the spread of COVID virus and if anyone is found to test positive, we will inform and discuss what we should do.
Thanks again.
 
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