Redica Responds is an article series where we take common/unique questions from customers and industry events and answer them with our data. Use the following link to look at all previous Redica Responds articles.
Since onsite inspections resumed in February of 2022, how many human drug GMP inspections have resulted in a 483?
On February 7, 2022, U.S. domestic onsite FDA inspections resumed following a pause in most inspection activity due to the COVID-19 pandemic.
Since that date, 180 FDA inspections for human drug GMP sites in the United States resulted in a 483, out of a total of 186 domestic inspections in the human drug GMP space. That is almost a 97% chance of receiving a 483 observation.
Of these 180 inspections, 92 were surveillance inspections while 47 were for-cause inspections and 25 were for pre-approval.
From this limited data, it appears that a site is almost twice as likely to receive a 483 observation following a surveillance inspection as a for-cause inspection.
For all FDA inspections globally, the total number of human drug GMP inspections that have received a 483 so far this year is 257. Keep in mind, however, that FDA only resumed foreign inspection in Q2 of 2022.
Know Your 483 Observation Trends
When it comes to staying on top of 483 observation trends, it is helpful to have an idea of what FDA investigators are increasingly focusing on. Investigators want to see that quality systems are robust, cross-contamination prevent measures are in place, investigations are fully completed, data integrity procedures are strong, among other things.
How Redica Systems Can Help
It can be challenging to stay on top of global inspection trends. Redica Systems’ actionable intelligence gives you unique insight into every individual FDA investigator and the latest agency inspection trends across inspection types, including pre-approval inspections (PAIs), for-cause inspections, and routine inspections on all GxPs.
To learn more about how Redica Systems can help your team with inspection preparation, contact us to schedule a walkthrough of the platform.
Additional Inspection Preparation Resources
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