Failure to Police our Stability Contractor

A CDMO that we’ve been using for a little over three years has just notified us that the FDA has shown up at their door for an unannounced inspection. This CDMO handles 80% of our stability storage and testing and this is the first instance of exposure we’ve had to a physical inspection at their facility. We believe the inspection is part of a pre-approval for another company they are supporting, but our material is stored and tested right alongside that company’s product.

Our compliance group is concerned, because for the last year we’ve had trouble with this CDMO over several testing delays and some difficulty in obtaining raw data for review and generally weak communications. I don’t know if the company undergoing the pre-approval inspection has been having the same problems, but certainly the exception reports and other documentation related to our company are at risk of coming to light in this inspection. I’ll admit that we’ve been a bit hesitant to press hard for compliance and procedure changes since we were under the illusion that being a CDMO meant a lower risk of an FDA inspection. Hindsight’s 20/20.

A 483 would be devastating for us as we are a very small startup with not much clout with the agency or our investors. What advice can you give us to prepare for the likelihood that our product might get entangled with this inspection?

Continue to bury your head in the sand and hope for the best, but meanwhile, it might help to also have any printouts of key communications, procedure update requests and generally anything proving that your company has not actually buried their head in the sand for the last three years.