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FDA 483 #8 - Using ungraded ingredients

FDA 483 #8 - Using ungraded ingredients

Released Friday, 9th October 2020
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FDA 483 #8 - Using ungraded ingredients

FDA 483 #8 - Using ungraded ingredients

FDA 483 #8 - Using ungraded ingredients

FDA 483 #8 - Using ungraded ingredients

Friday, 9th October 2020
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In this weeks 483 Friday we're going to be talking about the use of ungraded ingredients in pharmaceutical preparations. First, I'd like to show you a 483 where this was done, then we'll look at a case where non-USP ingredients led to real issues in patients where the drug product contained non-USP graded ingredients.

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