Now What?

Stages of Grief (or, stages of the compliance journey)

  • DENIAL/ISOLATION: You received the warning letter and you tried some bandaids to get yourself out of trouble; you aren’t like THOSE guys, you just need a tweak here or there
  • BARGAINING: FDA snickered and said, “Nice try, but, no.” So, you hired Big Consulting Firm LLP to try and buy your way out of trouble.
  • ANGER: FDA did not laugh this time. They snarled. They said, “We don’t care that you dumped the gross national product of a small island nation. We don’t care that Big Consulting Firm LLP said you were okay. What we see is window dressing. Expensive, high-end window dressing.”
  • DEPRESSION: Now What?
  • ACCEPTANCE: You finally realize that the deficiencies in your quality systems are real. You have some systemic and cultural issues that need to be fixed. This is not something that someone from the outside can come in and fix. This is not a one-and-done project. It is at this point that you will find the right people to build a plan that will stop the bleeding, stabilize the patient, get you out of trouble, and set a course of healthy living so this doesn’t happen again.
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