Wednesday, May 8, 2019

Manufacturing Choice Matters

The Cadila plant in India has just completed their response to 14 citations resulting from their recent FDA issued 483 letter.  And in a hilarious example of spin, they present a perfect example of why you need to be careful when choosing a CDMO...

Can you imagine that you are in charge of the CMC for your company.  For whatever reason, you chose to go forward with Cadila and now this conversation gets played out...

You : Hi boss, can we talk for a minute?
Boss: Sure, what's up?
You: We have an issue with our CDMO that we need to discuss.
Boss: Really, what's going on.
You: Umm... Well... They were issued a 483 by the FDA
Boss: Ok.  That isn't good, but there are lots of kinds of 483 issues, what are the details
You: Well, actually that is a bit of a bright spot here.  They were issued 14 citations, but we are glad to say that they are 14 UNIQUE citations from the last 483 we were dealing with...

A CDMO has one job.  Prevent 483s through a rigorous standard of constant process improvement.  If you are looking for one. The inspection track record should be your first, and your last question.  Decisions are often made by prioritizing cost / timing / personnel instead.

Be careful out there.

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