Corrections and Removals - Fiber Content in our textile products was incorrect

S

sturey45

I have not been able to figure out how to start a new thread. I have a question about Corrections and Removals. We recently found out that the Fiber Content in our textile products was incorrect. Now, this mistake will not cause risk but it is misleading.

I believe we should be doing a removal, and notifying FDA. However, my bosses aren't going for that. Is this a case of needing to do a Removal?

What other guidance is there regarding a removal?

Thanks,
Stuart
 

Sulamistan

Moved On
You need to take a look at the following,

1. 21 CFR Part 806
2. 21 CFR Part 810
3. 21 CFR 16
4. Section 518

Hope this helps.
 
Top Bottom