Since the introduction of FSMA in 2011, the FDA issued new guidance to the Food Industry for GMP and HARPC (Hazard Analysis and Risk-Based Preventive Controls). This guidance was encapsulated in 21 CFR 117, which is slated to replace 21 CFR 110.
The biggest difference in 21 CFR 110 and 21 CFR 117 is that the FDA now expects proactive enforcement of standards versus reactive enforcement. Here is a handy guide we found from the FPSA to explain the differences.
So where are we now? The FDA started to issue 21 CFR 117 citations back in 2016, which has many companies scrambling to make sure they are in compliance with new FDA regulations.
We’re taking away the guesswork. Here is what we are seeing…
1. 21 CFR 110 is still (by far) the biggest game in town.
The first FDA inspection citing 21 CFR 117 happened back in May 2016 (not September like the FDA told you). Since then, we have been seeing an increase in the issuance of 21 CFR 117 citations, but as you can see below, 21 CFR 110 is still the lion’s share of the citations.
2. When 21 CFR 117 is used, it tends to be used stand-alone.
There was some thought that 21 CFR 117 would supplement 21 CFR 110 and even 21 CFR 123, but we see it being used stand-alone more often than not.
3. Warning letters have started showing up citing 21 CFR 117. Here are the first 2.
From what we can see, there have only been 2 warning letters issued that cite 21 CFR 117. One that was issued in conjunction with 21 CFR 123 and one that was issued in conjunction with 21 CFR 110.
4. Here are the top 21 CFR 117 citations since 2016.
The citations below account for ~75% of the total 21 CFR 117 citations that have been issued.
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About the Author
Michael de la Torre is the CEO of FDAzilla.
Paul Brooks is the lead FSMA/Food Business Development Representative at FDAzilla.