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?
Enforcement was light this week, including a single warning letter to a drug manufacturer in France. We cover it here.
In March of 2019, we added 216 483s to our database of 27,500+ FDA inspection documents.
Enforcement was light on warning letters this week: one to a device manufacturer, one to a compounding pharmacy and one to a homeopathic drug manufacturer.
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.
Have you clicked over to the FDA website recently? If so, you saw that the site has a whole new look and feel.
This was a very light week for warning letters with a total of two new ones posted by FDA. One was issued to a device manufacturer and we cover it here.
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.