10 Things To Know Before Writing An FDA 483 Response Letter

By Johanna Blair

So, you’re a medical device manufacturer and you just got a Form 483 or warning letter from the U.S. Food and Drug Administration (FDA). Now what?

The FDA requires a response to most compliance notices within 15 business days, so the clock is ticking! Time is of the essence when crafting a response letter and remediation plan. Learn the details of the 10 things you should do as soon as possible:

1. Start preparing for your FDA 483 Response immediately
2. Get outside remediation help
3. Don't make quality compliance assumptions
4. Be brutally honest about nonconformance
5. Designate department roles in you Form 483 Response Letter
6. Divide and conquer FDA Warning Letter observations
7. Don't speculate in your FDA 483 Response Letter
8. Go above and beyond the Form 483
9. Address timelines, but be realistic
10. Look for trends that may lead to future FDA Warning Letters