Archive for September 27th, 2017

Why is the FDA still finding basic nonconformities in manufacturing?

Every so often, I take the time to catch up on the FDA’s findings that result from the latest audits of drug, device, biologics and combination product manufacturers. It always astonishes me as to how these nonconformities occur, namely because the findings seem like simple issues that can be easily avoided. Throughout my career, I have seen various incidents like these occur, such as while walking through the manufacturing areas on the way to my workstation, conducting internal audits, performing supplier audits, or being audited by the FDA.

It occurred to me while I was reviewing these findings that if I think these issues are a simple fix, my guess is others will too, and by bringing awareness to these issues maybe it can prevent some headaches for the next company to be audited. If you’re looking for some insight into what the FDA is still finding, these are just a few of the findings that I came across. Read more »