Friday, December 2, 2011

FDA on pace for record year issuing 483s

FDA Form 483Zymergi serves companies that run cell culture and fermentation processes. Nearly all our customers produce biologics... molecules that are synthesized by biological organisms - and all of them get their GMP plants inspected by the FDA.

Yesterday, FDAzilla published the rate the FDA hands out inspection observations called 483 for 2011. It's eye-popping; on average, they hand out 1 (Form) 483 every 50 minutes.

If you need more information on avoiding headache with the inspectional liability side of running cell culture/fermentation processes, go ahead and visit:

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