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May 12 , 2009



If Today an FDA auditor arrives unannounced to your Pharmaceutical Plant, there is a 54.1% chance that you will be receiving a dreaded 483 with a list of observations.
As a professional you need to know, for yourself, what the FDA is focusing when assessing Pharmaceutical operations.
You will find here:
5 FDA Observations:
1.Observation for Training.
2.Observation for Facilities and Equipment.
3.Observation for Quality systems
4.Observation for Production Systems.
5.Observation for Cleaning Validations

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About the Author
Dave Cortés is CEO and Founder of Born on New York and raised in Puerto Rico, Dave Cortes is a professional engineer, certified Lean Black Belt and Project Management Professional. He has worked on Pharmaceutical and Medical Device industry for the past 16 years.

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