CA FDA came and went

Posting has been non existent over the past few months as I've been pursuing some other projects in my free time and I like to let this blog run at least a couple months behind what is actually going on with the company, but I'm good for a post now.

The California FDA (or really DHHS) inspection mentioned before went well, with just three findings about the quality system that needed updating. The inspector spent two days on site and worked until about 3 PM both days and took quick lunches in the car. The big finding was the supplier management SOP needed better definition, what is a critical supplier, and what does that mean in terms of incoming inspections and audits. The trick to this is making a procedure where you focus on the suppliers that actually need it and don't waste your time and money. Suppliers that do not necessarily manufacture medical devices full time are a good target, hello PCA manufacturer. While sterilizers and GLP testing labs are arguably critical vendors, you're probably not going to catch them doing anything significantly bad unless you're willing to spend a week there, let the big fish do that, I want bang for the buck.

The second finding was a minor note that it was not clear how exactly it would be decided a customer complaint required a medical device report (MDR) incident. The third finding was another minor note that the CAPA chain was unclear, although I thought this one in particular was not an issue, but it is easy enough to do a small update to the procedure so I only spent four hours arguing the point. There were other comments, but those were the three that had to be responded to.

We also heard back on ISO 13485 and the CE Mark, as well as responding to and hearing back from the Federal FDA regarding our 510(k), but I will leave those updates for another day.