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Top 2018 FDA Inspection Observation Categories

Each year the FDA provides spreadsheets summarizing the areas of regulation cited in these observations at the following website:  The spreadsheets are not a comprehensive listing of all observations but represent the a number of times it was cited as an observation on a FDA Form 483.     Top categories for 2018: #1 Quality…

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Metrics, the Foundation and Emotions

Metric Reporting

Metrics, This one word can cause many emotions, fear, trembling, excitement, or dread! I have experienced all of these emotions when it comes to metrics. That Pareto Chart ascending or descending in at a particular elevation or curve can have a profound effect upon us! The FDA has recognized the importance of Quality Management System…

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