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Top FDA 483 Observations

Top FDA 483 Observations, for Medical Device, Drugs, Biologics 

Every year, PathWise complies information of the top FDA 483 observations from their inspection observations. View trends! For example, did you know Corrective and Preventive Action, 21 CFR 820.100 has been the number one observation for almost a decade?  See what all the hot topics and common violations are so you know where to start improvement projects in your quality systems!

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RESULTS FROM 2015 483 Observations

Medical Devices

 

Drugs

 

Biologics


Top Regulations Cited in Warning Letters, 2015

Medical Device

 

Drugs

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RESULTS FROM 2014 483 Observations

Biologic:

Pharmaceutical:

Medical Device: