Most companies want to avoid FDA warning letters.  To help medical device companies identify violations that might lead to a warning letter, this post will dive deeply into which specific types of violations are often found in warning letters that FDA issues.

Background

As you probably know, FDA has a formal process for evaluating inspection records and other materials to determine whether issuing a warning letter is appropriate.  Those procedures can be found in chapter 4 of FDA’s Regulatory Procedures Manual.  Section 4-1-10 of that chapter requires that warning letters include specific legal citations, in addition to plain English explanations of violations.  The citations are supposed to make reference to both the statute and any applicable regulations.

As a consequence, to understand the content of the warning letters, we need to search for both statutory references as well as references to regulations.  Because statutes are deliberately drafted to be broader in their language, references to the regulations tend to be more meaningful.