We Will Survive (FDA)

At first we were afraid, we were petrified

Were deviations closed, batch records verified?

But then we spent so many days with our captors in a room

A certain eerie calmness replaced pervasive gloom

 

Then they came back, most every day

And going on week 3 we thought “they’re always going to stay”

But then we glimpsed a tiny light, we were almost at the end

And just like in Stockholm syndrome they almost felt like friends

 

So go on now, walk out the door
You said this Inspections over

Well, you're not welcome anymore
There is nothing else that you can find for your 483

And I’m not sure

How much more

We can take this third degree

We will survive!

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It took all the docs we had, but we showed control

Our excellent procedures we could all extol

Our executed validation protocols were fine

Our maintenance activities were always done on time

 

The Assays in our QC labs were run with care

Only qualified suppliers were used anywhere

Our QA was on the ball, our Manufacturing was great

If only that response last time wasn’t done so late!

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But we’ll not die!

I’ll clarify

Even with their observations this company survives

And per Nietzsche, that which fails to destroy us makes us strong

Moving forward we’ll be better

Our future will be long

We will survive!