FSMA Has Arrived – Here’s What We Know So Far

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.

Like This & Want More? Sign up to get free weekly content updates designed to make your job easier.

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.

Next Steps

How do you make this actionable?  How do you get the analytics to apply it to your sites, your suppliers, and your competition?

That’s where FDAzilla comes in.  With our unmatched FDA inspection database, going back to the year 2000, combined with our analytics and monitoring tools, you can get the actionable intelligence you need to stay one step ahead of the FDA.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at sales@fdazilla.com.

Like This & Want More? Sign up to get free weekly content updates designed to make your job easier.

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”1646″][fusion_global id=”1649″]

Like this post? Don't forget to share it!

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print
Govzilla Bug

Don’t miss out! Subscribe now

Experience the Power of Govzilla

Get your FREE account to search sites, inspections, & warning letters