Should you be?
Many companies fear FDA. Some probably should because business practices, documentation and records, and compliance are not up to snuff.
Many years ago, the company where I worked was preparing for ISO auditors (not really like FDA inspectors but kind of) to come in for recertification. I speculated that the office chatter was probably similar to Paul Revere’s midnight ride: “The auditors are coming. The auditors are coming!” Several of my colleagues would remind me of this several days ahead of time. This was puzzling to me. I responded by asking why wouldn’t we act / do the same things whether auditors were present or not.
And it’s true. If you are afraid of the FDA (or ISO), you probably have one of two reasons for this fear:
- You know your company is out of compliance.
- You don’t know what you don’t know.
In either case, I would encourage you to seek help to remove your fears. Find a company, consultant, or resource to come in to help (hint).
Or you can roll the dice and wait for a FDA inspection and take your chances.
