Wednesday, September 21, 2011

Will the FDA issue 10,000+ 483s in 2011?

FDA will issue 10,000+ 483s in 2011 – one every 52 minutes FDAzilla Blog:   'via Blog this'

The number is kind of shocking!  According to the FDAzilla Blog:

"Based on new data obtained by FDAzilla, the FDA should surpass 10,000 483s in 2011 for the second time in its history, breaking its all-time record for the third consecutive year."
According to e-How - The Definition of FDA 483:
FDA Form 483, is the form on which inspectors for the Food and Drug Administration detail unsatisfactory results of their inspection of manufacturing facilities for compliance with current good manufacturing practices (cGMP). The FDA inspects plants making human drugs (both prescription and over-the-counter drugs), animal and veterinary drugs, medical devices, food, radiation-emitting products, vaccines, blood and biological products and cosmetics for compliance with cGMP.
You might also be interested in:

Inspection Detection - a GMP training game by SkillsPlus Intl Inc.
An extensive library of 483 citation summaries from the FDA. Match the case with the corresponding 21 CFR 211 reference. Used as a classroom training tool or for self-study, this training aid challenges the student to identify and justify the 21 CFR 211 reference that supports the 483 citation.
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1 comment:

Fioricet 180 said...

Thank you very much for - Extensive library of 483 citations resume from the FDA.

From SkillsPlus International Inc.

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