From The Editor | September 25, 2017

How To Always Be FDA Inspection Ready

Sam Lewis

By Sam Lewis

Be sure to watch the entire web chat

The Grocery Manufacturers Association (GMA) and Hogan Lovells partnered with Food Online for a live web chat, Food For Thought: How To Always Be FSMA Inspection Ready. Here, Elizabeth Fawell, food industry counsel at Hogan Lovells; and Samantha Cooper, senior manager of food safety and quality assurance at GMA, join Food Online’s editor, Sam Lewis, to answer the food industry’s questions on how to always be ready for FDA inspections.

Sam: Hello, everyone, and thank you for attending today's web chat. I'd like to thank GMA and Hogan Lovells for partnering with Food Online and providing us with excellent subject matter experts on this important and timely topic. And thank you, attendees, for joining us.

It's my pleasure to introduce to you our subject matter experts. We have Elizabeth Fawell; food industry council at Hogan Lovells, and Samantha Cooper; senior manager of food safety and quality assurance at GMA.

Elizabeth is a food industry lawyer with Hogan Lovells. As food industry council, Elizabeth navigates complex regulatory issues confronting food companies and helps them understand both the rules and various risks involved with them so they can make informed business decisions. Elizabeth works with every segment of the food industry, including manufacturers, distributors, retailers, and their trade organizations. She has worked with food companies on FSMA since the legislation's inception and her understanding of HACCP systems has provided her with the perspective needed as she council's clients on how to comply with the law. Elizabeth provides clients with real-time advice during factory inspections, help clients prepare 483 responses, and drafts inspection manuals. She is also a Preventive Control's Qualified Individual, having completed the FSPCA PCQI training. Elizabeth, that’s quite an impressive resume, thanks for joining us today.

Elizabeth: Thanks, Sam. It’s a pleasure to be here.

Sam: We also have Samantha Cooper, senior manager of food safety and quality assurance at GMA. In this capacity, she works with some of the world's largest food companies to identify, develop, and recommend solutions to ongoing and emergent scientific, regulatory, and public policy issues affecting the food industry. Samantha is an International HACCP Alliance lead instructor, FSPCA human food lead instructor, and an FSPCA Foreign Supplier Verification Programs lead instructor. Prior to GMA, Ms. Cooper gained experience as a food safety manager at a sous vide manufacturer and completed a management training program at a poultry processing facility. Samantha, as always, it's a pleasure to have you with us.

Samantha: Thanks, Sam. I’m happy to be here today.

Sam: It's great to have you both with us. So, here's what we have in store. Our goal is to explain FSMA's basic requirements, why complying with them is essential, and describe what to expect when the FDA arrives at your facility for a FSMA inspection. Most importantly, we will spend much of our time addressing and answering your questions; feel free to admit them at any point during our chat.

Let's get started. Samantha, can you give us a broad view of today's topic, its importance, and some of the challenges the industry is facing with it?

Samantha: I'm sure many of you are probably already aware that FSMA inspections are here. Domestic and foreign facilities producing human food fall within the General Compliance date, September of last 2016. They have been undergoing modernized cGMP inspections, as well as Preventive Controls inspections. For those of you who fall under the Small Business Compliance date, your compliance period starts on September 18. This webinar's pretty timely for those who haven't experienced an inspection yet.

In addition to our Preventive Control inspections, we also have the Foreign Supplier Verification Program (FSVP). The FSVP inspections have also begun. This involves the FDA inspecting those U.S. based importers and their programs to verify that their foreign suppliers are producing safe food.

We’ve noticed that those inspections have been very interactive and cooperative. The FDA's goal is to gain industry compliance while reducing foodborne illness. To achieve this, the FDA has taken an “educate-before-and-while-we-regulate” approach. This is to help educate industry on the new FSMA requirements. In addition to educating industries and the FDA investigator, the agency is also taking appropriate regulatory action when needed. The FDA only intends to document the serious items that are linked to public health outcomes on the 483 form. The other items may need digression points during that close out meeting of your inspection.

ElizabethElizabeth: In terms of inspections and what they look like, inspections are very document heavy. Remember that the major change, with respect to FSMA and how it effects inspections, is its respect to records access. The FDA now has access to records during routine inspections that, historically, they have not had access to. That really changes the nature of the inspection. You need to be prepared and organized and ready to share those records with the FDA.

When we're talking about records, we're talking about your food safety plan. This includes your:

  • Hazard Analysis
  • written Preventive Controls — which includes things like supply chain program and recall plans
  • Monitoring Procedures
  • Corrective Actions
  • Verification Procedures
  • Implementation Records

These records will show you followed your plan and carried it out on a daily basis. Records are really important; they are how you show the FDA you're doing a good job day in and day out when the inspector isn't there to make observations. They really become the face of your company, so I can't put enough emphasis on the importance of records and making sure your records show what you're doing. The important mantra to remember is, "If it isn't documented, it didn't happen. If it is documented, it happened just that way." Your records will stand on their own and say what you did or didn't do.

It's important to work with the FDA to correct any deficiencies noted during an inspection, even if those are items that seem minor. Go ahead and take those corrections during the inspection and point them out to the inspector. Particularly, if the inspection lasts more than a couple of days, even if it take you some time to put in a change. If you have that correction accomplished before the close out meeting, page the inspector back and say, "Look, I want you to see that we fixed this, that we're listening to you.” As mentioned earlier, the FDA is taking an “educate-before-and-while-we-regulate” approach, so you can really learn from the FDA about why the deficiency was noted and how your firm can improve or correct the situation.

The final introductory point is a culture of food safety matters. This is something the FDA is looking for. This is not a quantitative thing that can be analyzed; it's much more of an impression. It's about whether the facility makes the right decisions to produce safe food and whether food safety is a priority for the company and the employees. This can be seen through your records, as I mentioned, because they've become the face of your company, but also through the observations the agency makes during the factory tour while looking at the conditions of your factory, as well as the behavior of employees. Do the employees look like they're performing their job well? Can they explain their role? Do they know what they're supposed to do and their role in food safety? Things like that. A culture of food safety takes a lot of time to develop, but it's a really important asset of putting forward a good impression for FDA during an inspection.

With that, I think we can jump into answering some of the audience’s questions.

Sam: Yes. Thank you both for your insight on getting the chat started. Questions have been pouring in from our audience and we'd like to start addressing them.

This first question is going to go back to the first bullet point of our previous slide and it says, "How soon will the inspections start after FSMA's implementations?” We know that this is different per business size, so the answer could vary a little bit. Samantha, would you like to address this one?

Samantha: Sure, thanks Sam. Just to start, we keep hearing “FSMA inspections,” and I think it's important to point out that there are seven foundational FSMA rules. We try to call them out because they do have different requirements. For the Pentavalent Controls for Human Food Regulation, if you fall within the general compliance period, which is over 500 full-time employees, the modernized cGMP Preventive Controls inspection started last year.

Like I said in the introduction, if you're a small company or a small business (less than 500 full-time employees) you could see an inspector show up sometime very shortly because your compliance period starts September 18. If you're a small business, you know, look out for that. Inspections for very-small businesses will begin in 2018.

For those of you who produce animal food, we’ve also seen that the Preventive Control for animal food modernized GMP inspections have started. The FDA announced that the inspection for the Preventive Control portion of that will be delayed. We also see that FSVP inspections have started. However, the compliance dates for those can be a little bit complicated, so it's really important to go online. The FDA posted a guidance document that can help you identify when your compliance period is. We also have the Sanitary Transportation Rule, we've heard from the FDA that inspections for that could start sometime later this year.