May 16, 2008

California FDA inspection

Since we moved the company we're waiting around for a state of California FDA inspection so we can manufacture medical devices for clinical use. We waited until we were mostly all set up before telling them about the move, which was way too conservative because they are doing inspections 3-4 months after they receive the application (like it says on the website...), we should have told them immediately about the move. Our previous state FDA inspections were nothing more than top level SOP reviews, although I talked to a QA at a large pharmaceutical company in the area and they said their state FDA inspectors looked at everything.

In the meantime, I think I've convinced everyone to build samples for a full sterilization validation and some other bonus testing. This way we can stop screwing around with lot to lot validation which takes a lot of time and money. Plus I think product workmanship will improve with practice and we'll be ready to go more quickly when we do get approval.

1 comment:

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