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GMP News

Root Cause Analysis: What can be found in FDA Warning Letters?

We recently reported on the issuance of two FDA Warning Letters, which included observations on inadequate root cause analysis (RCA).  However, also in other Warning Letters issued, insufficient root cause analysis is cited and seems to be a frequent finding in FDA inspections.

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FDA criticises the Use of pharmaceutical Facilities for industrial Products

Recently, several Warning Letters have been published by the US FDA criticising the use of non-dedicated equipment for pharmaceutical and non-pharmaceutical products. In a recent Warning Letter, this is once again made very clear.

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Do you want to host FDA Staff? FDA announces Experiential Learning Site Visit Program

The FDA is announcing a program to enhance FDA's understanding of pharmaceutical manufacturing processes, innovations, and industry challenges. The program relies on pharmaceutical manufacturers, who host FDA staff at their facilities.

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