Did you know that “data integrity” is the second most-cited keyword in CDER warning letters? Or that it ranks 33rd of 483 cited keywords?
In March of 2019, we added 216 483s to our database of 27,500+ FDA inspection documents.
In February of 2019, we added 167 483s to our database of 27,500+ FDA inspection documents.
In January of 2019, we added 222 483s to our database of 27,500+ FDA inspection documents.
When it comes to scanning 483 observations, can a 15-second search replace hours (or weeks) of research and still provide enough data? Yes, and more.
CDER inspections in the Asia Pacific region are up 103% since 2013. How has that influenced enforcement actions? And what about your supply chain?
Overall, global CDER warning letter issuance has skyrocketed. Here we review the trends over the last five years in regard to facility type.
We put together the ultimate guide that will give you an industry primer for everything you need to know about Form FDA 483s.
FOIA requests are not being processed at this time. Fortunately, we have the largest library of FDA inspection documents available.