Tuesday, August 28, 2012

1,000 #FDA 483s!?! @fdazilla

Check this out:


FDA 483 Store

It's basically a place where you can search and buy one-thousand FDA 483s reports.

 Here's what a search for Amgen's 483s look like:

fda 483 store/></a>
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You get the goods:<br />
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Click into the 483 report and see the details:
  • Number of observations
  • Inspection Time Range
  • Investigators

fdazilla 483 store individual 483
Add To Cart and checkout with PayPal.
It's strange because when you're running cell culture production in GMP environments, QA sort of gets these communications and plan their inspection readiness strategy around these 483 reports.

Next thing you know, you're at a change management meeting and you're trying to address all these new requests and can't figure out the drivers for them...

Well, here they are: 483 observations that FDA inspectors make of other plants will also apply to you.

p.s. -  This is, of course, in addition to their FREE 483 offering I wrote about a while back.

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