Over the years, we’ve written quite extensively about avoiding 483s. Here’s a summary of some of the most timeless advice and perspective.
While the technologies change and the areas of FDA emphasis change quite a bit, the basics of inspections don’t change. Here’s 7 basic strategies for avoiding FDA 483s. Like the saying goes, sometimes common sense isn’t so common.
- Document, document, and document more
- Shore up quality control at release time
- Lock down validation controls
- Make sure your written procedures are rock-solid — and follow them
- Don’t neglect your physical plant
- Don’t make the FDA tell you a dozen times
- Get serious about employee training
The X factor in avoiding 483s is something that sounds soft and squishy, but is terribly important and requires leadership from you: a healthy company culture.
We dug back into the archives and found these 3 FDA 483-related trends back in 2012. Oddly enough, these trends are still mostly true today.
- FDA is planning stiffer penalties
- International Inspections are intensifying and on the rise
- US Inspections are intensifying (Inspections have been down in 2014. Lots of reasons as to why, here’s 3)
Bonus: 3 tips for inspection day