The “Warning Letter” is considered by FDA to be the first step in the enforcement process, and a firm’s response to it may be its last chance, prior to a legal or administrative action, to adequately address a situation that FDA has concluded constitutes a violation.
You don’t want to get one of these!
Understand the regulations & avoid unnecessary citations.
This is one of the top 10 reasons why medical device manufacturers are issued with warning letters.
Excerpt from actual FDA warning letters issued recently.
“21 CFR 820.22 – Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.”
Want to understand 21 CFR Part 820.22 and help your company avoid these issues?
Watch the video above to find out how to avoid this.