It’s Friday. 8:30am. You’re looking forward to a long, nice weekend. Then, you get a call from one of your associates. An FDA inspector is waiting in the lobby. She’s unannounced, she’s experienced, she’s eager, and she’s ready to go.
Do you know the feeling? That feeling of that pop quiz in your least favorite subject in middle school. times 1,000,000. Oh, man, not today.
Based on our FDA 483s statistics, this is probably happening somewhere in the world right now. In 2011, there was a 483 issued roughly every 50 minutes. And of course, those don’t even count the inspections that didn’t yield a FDA 483.
We’ve noticed a very interesting phenomenon. In fact, this happened just this past weekend. After a stressful day, the inspector has left for the day. It’s time to head home . It’s Friday night, and you ask someone of your team to google the inspector. For example, try googling “Noreen Muniz FDA inspector”, and you’ll get this. Why not try to find some intell on the person you’ll be spending the next week with?
So, the regulatory team ends up purchasing all the 483s that their inspector has issued previously – or at least, the ones that are regularly available. For Norren Muniz, we have 17 FDA 483s. From that set of data, maybe it is possible to spot trends or tendencies? Sort of like what those NFL coaches do – watching all that film of the opponents they’re about to face. At the very least, it would make sense to check out the latest available 483. After all the FDA has stated in not so many words, that they expect us to learn from the mistakes of others, and not to repeat them.
Nonetheless, this was part of the reason why we’ve decided to enable you to identify 483s by inspector. One of our customers this past weekend bought one 483 at 9:30pm Friday night from us, and then another 3 at 10pm. Then, they bought all the rest from the same inspector Monday afternoon.
Check out our new 483 store – searchable by address or company, and tagged by inspector. And now, we have more than 1,000 483s available for immediate purchase and download.