I wish the tale I’m about to share is hypothetical. It’s not, however.
Several months ago, I was contacted by a small medical device company. The initial conversation led me to believe the company was being somewhat proactive about making improvements to its quality system and internal processes in the spirit of continuous improvement. The company asked me to provide a proposal to revise their QS.
A few weeks went by. The only update provided was the proposal was being reviewed and discussed by the board. Weeks turned into months. No decision.
And then FDA came in for a visit, almost three years to the day from the last FDA inspection. I was asked to participate in the closing meeting. No surprises from FDA. All the 483 observations had been identified by me and others prior to FDA showing up. Despite having a thorough list of issues to address from the FDA inspector, the board was still reluctant to take action.
The initial response of the FDA inspection was drafted by the company within a couple weeks. Commitments were made, including the date for the next follow-up with FDA to be sent about a month later. Despite time ticking and check-ins by me, the company was still sitting idle, doing nothing to address the 483 observations.
Two weeks prior to the next FDA response, the board decided to have a meeting to discuss the observations, among other business issues. I was invited to present my opinions on the matter.
After the board meeting, more indecision. No actions being taken. The date for the FDA response was a couple days away now. I strongly advised that the company still send in an update, even if there was very little to report.
The company chose otherwise. I followed up with them seeking an explanation for why. I again encouraged them to still send a follow-up to FDA, even though it would be late.
Not sure if they ever did.
I don’t understand why a medical device company would take this approach with FDA.