AFI Association of Food Industries

AFI Serving the U.S. Food Import Sector

I’ll Deal with FDA’s FSMA Regs If They Ever Come to Inspect Me!

29 Mar 2021 9:21 AM | Deleted user

I had someone say something like that to me when I bumped into him and someone from his company at a trade show a couple of years ago. Since FDA was actually coming to his office a few days later to conduct a Foreign Supplier Verification Program regulation inspection, his comment was more along the lines of “I’m not going to keep all those records. If I don’t have something, I’ll just tell them I need time to get it and they’ll just have to give me that time.” Based on the look his associate gave me, he wasn’t at all comfortable with that approach – and rightfully so!

I’ve heard both of these statements and both are troublesome. Is the first time you hear about or think about getting the documents importers are required to have to comply with FSVP going to be when FDA arrives at your office? As with every other social interaction, first impressions go a long way. You’ll get your FSVP inspection off to a rousing start if you take this approach.

FSMA was signed into law 10 years ago. The first compliance date for importers was in 2017. FDA rightfully expects importers will have taken steps by this point to comply with the regulation. The cavalier approach of acting as though you can make FDA wait until you have time to start taking things seriously will have serious ramifications on your business.

If, on the other hand, your firm has taken steps to do what’s necessary to comply, FDA is still using enforcement discretion. That means an FDA investigator is more likely grant some leeway and give some time to correct shortcomings to a firm that’s made a concerted attempt at compliance.

The Food Safety Preventive Controls Alliance, a public/private partnership funded by FDA, developed courses for some of the seven major FSMA regulations. I strongly recommend you take the course(s) associated with the rule(s) to which your firm is subject. It’s the best way to get the information you need to comply and it’s delivered in a way that facilitates understanding of the rules. I served on the task force that developed the FSVP course and lead AFI’s FSVP training. Click for detailed information.

Whether it’s through AFI or another provider, take the training and get your suppliers to take the course on the Human Food rule – the one for food producers. 

Association of Food Industries: Serving the U.S. Food Import Trade Since 1906
3301 Route 66, Ste. 205, Bldg. C • Neptune, NJ 07753
(732) 922-3008 • Fax: (732) 922-3590 • •