Failed to conduct adequate investigations into these significant deviations prior to making batch disposition decisions

This is continuous to previous post about FDA observations 1,2 of 4.

3.      Failure to ensure all production deviations are reported and evaluated, and that critical deviations are investigated and conclusions are recorded.

Our investigator’s review of your 2014 and 2015 annual product quality reviews (APQR) revealed that your firm had eight critical process parameter failures related to time limits for (b)(4) or (b)(4) operations under (b)(4) conditions for (b)(4) USP API. 

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FDA cGMP violations and Quality assurance has took failure decisions

With this article we would like to share you about 2 of 4 FDA cGMP violations which teach about cGMP from where non GMP activities went. (Click here to read about observation 1 of 4) 

Learn observation 2: The inspector has identified that the API product has been released without testing mandatory tests.

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FDA cGMP violations which teach about cGMP from where non GMP activities went. Learn about effective CAPA system

FDA cGMP violations which teach about cGMP from where non GMP  activities went. Learn about effective CAPA system .

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