FSMA Inspections: What To Expect When The FDA Knocks On Your Door

By Sam Lewis, editor, Food Online

Be sure to watch the entire web chat or read part one of this series

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 discuss some of the difference between current and past FDA inspections, as well as what goes into a Foreign Supplier Verification Program inspection.

Sam: What are the differences we'll see in current and upcoming inspections compared to earlier FDA inspections? Elizabeth, can you give us some insight about what you are seeing and what you expect in the current and upcoming inspections versus inspections of the past?

Elizabeth: One of the most important differences that we'll see is the FDA's broad record access that is granted under FSMA. The records access extends to all of the rules: Preventive Controls ... for Human Food, or Animal Food, Sanitary Transportation, et cetera. If the FDA requires a record to be kept, then they have access to those records under those rules. That's really one of the significant changes in how inspections will feel.

With respect to that, the FDA is going to be looking at the adequacy of your program; so what those records say about how you've designed you food safety system. Have you identified the right hazards, the right controls, and things like that? They will also be looking at how you implemented those systems.

The FDA is going to notice if records are not signed and dated; if it doesn't look like the record review occurred, if there's a monitoring record missing, and things like that. Corrective Action records: if you haven't documented that you took a corrective action, then it didn't take place. That record change is really the most significant. The FDA is taking a much more systems-based approach to its inspections. We're really going to look at the food safety system comprehensively. Again, how you've designed your food safety plan and how you're implementing it.

I think FDA inspectors have undergone a significant amount of training to conduct these inspections, so we will see a more collaborative approach. That doesn't mean that inspectors won't be in learning mode, it depends on when you get an inspector. Particularly on the Foreign Supplier Verification Program (FSVP), it might be their first inspection under FSVP or an early one, and they're certainly still learning some of the regulations themselves. These inspections will address firms that have never been inspected before, for example: importers. I know the Foreign Supplier Verification rule; if you meet the definition of an importer and you're declared as the FSVP importer then you can be subject to an inspection by the FDA.

I think it's also important to clarify, with respect to Preventive Controls inspections, that we actually have two types of inspections. Sometimes, an inspection will be a "FSMA inspection,” but the FDA will be inspecting with respect to the modernized GMPs. It's going to feel much more like a traditional GMP inspection, but the FDA is also going to be looking at employee training, records of employee training, and then they'll probably do a high-level review of the food safety plan. They'll ask to see it and look for red flags around pathogen and allergen control. It could expand into a full Preventive Controls inspection. But really, it will be that modernized GMP inspection and will be probably about two days or even less, depending upon the size of your facility.

The other type of Preventive Controls inspection is the full Preventive Control review of your food safety plan. This is a much more in-depth look at the food safety plan where the FDA is going to conduct its own hazard analysis, compare that against your hazard analysis, look at your controls, look at your procedures, and your implementation of those procedures and your records. That kind of an inspection will take several days. Again, it will depend upon the complexity of your plan and the size of your facility. That in-depth review of the food safety plan will take much longer. Even a full Preventive Control inspection with review of the food safety plan includes a walk-through of your facility and an observation of GMP conditions in addition to that food safety plan. It's important to understand what kind of FSMA inspection you're actually undergoing. I think it will be very clear if you're undergoing an FSVP inspection.

Don't hesitate to ask your inspector what type of Preventive Controls or FSMA inspection, if this is a modernized GMP or a full review of the food safety plan so you have clarity about what kind of inspection you're undergoing.

Sam: Elizabeth, your response sparked our next question. It reads, “How are food importers or distributors supposed to prepare for FDA audits?” Obviously, they're going to be part of FSVP, what would you recommend they do to prepare for FSVP audit?

Elizabeth: The most important thing is to understand and to be able to explain your own program. If you are the FSVP importer, what is your program? How is it identified as a whole? Who have you identified, if you've identified an individual person as being the FSVP importer for your company? Is that person prepared to answer questions? Who do you want in the room with the FDA in order to walk through the program?

I think it's really important to make sure that you have all the required records under the FSVP program; that you should prepare by doing a cross-check, making sure that you have all the documentation required. Again, do a mock inspection. Be prepared to answer questions about your program. Do a test run. Make sure that you've got all your records handy and make sure that you can explain your program well.

FSVP inspections have started, there haven't been too many of them, but there have been a few. Generally, these are conducted by someone in the FDA's import division from the district office. This type of inspection is not technically an inspection because it's not an observation of the facility where food is manufactured, processed, packed, or held. It's really a records review. You actually will receive the form 42 D, which is a different form from the 42 A, and that formal request to review your FSVP record. Typically, you're provided with advanced notice of an FSVP inspection, usually about 24 to 48 hours so that the right people are ready. That is not something that is necessarily going to continue. The FDA has indicated, for the time being, that they will continue to provide advanced notice. It's certainly been very helpful to the companies that have undergone an FSVP inspection.

The FDA will identify which line items from entry, at customs, it's going to be reviewing during that inspection. They'll say, "You've imported canned tomatoes on September 10th, show us the FSVP program for this product and supplier." So far, they've really focused on your hazard analysis to make sure that you've really identified the right hazards in that product, and making sure that those hazards were controlled by that supplier prior to import. It's pretty rare to have a 43 A issued. I have seen some instances where those have occurred, but most likely, you're going to receive discussion items and improvement items for your FSVP program as opposed to an observation form.

Samantha: I think that was a great review. We've also heard a lot of, "FSVP is new." There is still a lot of confusion out there, so it's really important that you do take the time and read the regulation, of course. Also read the preamble, you can download off the federal register. That will give you FDA's current thinking if you have addiction questions leading to FSVP.

There's also another curriculum developed by the Food Safety Preventive Controls Alliance (FSPCA). They have a course that you could take that will help you better understand the requirements of FSVP. The requirements and inspections are going to be conducted at locations and they're going to be asking questions to individuals that have never had any conversation with the FDA ever before. This is a new regulation and there are going to be lots of questions. There's going to be a really big learning curve for a lot of people out there.

Sam: With FSVP being such a new regulation and very few inspections have happened, it's going to be an industry-wide effort to share your knowledge with one another to ensure everyone's prepared.

Moving onto our next one, I'm going to bring it out of the nitty-gritty and maybe bring it to the higher level of the inspection process. Samantha, our next question reads, "Have inspections been at the plant level, or have you seen any at the corporate level?”

Samantha: We do know that some of the programs are sometimes developed and managed from the corporate level. However, it will be the facility implementing the program under the inspection. When an inspection is conducted, it is performed at the facility level; this is a facility-specific regulation. I'm talking in regard to the Preventive Control rules, both for human and animal food. It is a facility-specific program, so the FDA will be conducting the inspection at your facility.

However, we have been seeing that the facility will reach back to corporate when they need some help or clarification during inspection. This is particularly in regard to supply chain programs. Many times, it conflicts that I've seen managed at a corporate level.

Elizabeth: I would like to emphasize that for FSVP inspections, it depends who is declared as the FSVP importer and the address that you list, that's where FDA will show up for the FSVP section.

Sam: In your description of the FSVP inspection, Elizabeth, you said that normally facilities are given 24 to 48 hours’ notice. This question is asking, “Will the FDA also give advanced notice for any of the other types of audits?”

Elizabeth: A domestic inspection is going to be unannounced. However, when it is Preventive Controls or GMP, a foreign Preventive Controls, or GMP inspection will also be announced, because the FDA scheduled those. If you have a facility in Mexico, France, or China, that produces food for consumption in the U.S., then they are required to be registered and subject to the FSMA rules. The FDA can inspect those facilities and typically sends advanced notice in order schedule those visits. They typically will visit multiple facilities within a given area or jurisdiction, in terms of being efficient with their own travel plans and resources. You will have advanced notice when a foreign inspection will take place.

Sam: I'm going to take us back other level. We all know that there are seven pillars of FSMA, one of them being food defense, or intentional adulteration. This question asks, “When is the guidance on FSMA's intention adulteration coming via the FDA in training?” There's a big difference between food safety and food defense. A lot of people are still up in the air about, "What do I need to do to distinguish between the two and how to I prepare for that?"

Samantha: The honest answer is that I don't think anyone knows except the FDA. I think we're all wondering and hoping the same. We all want to see guidance and start developing our programs, and for those rules already in place, you want to be able to compare that to the guidance documents that come out.

We know the FDA is hard at work on these different guidance documents including the Intentional Adulteration rule. In addition to the IA rule, the FDA is also collaborating with the FSPCA, that I mentioned earlier.

We do know that one day, training will come out. But, again, keep checking the FDA website. If you aren't signed up yet, you can also sign up for emails from the FDA, so as soon as it gets posted you'll get a notification. Until that time, all we really have is the preamble to the rules, which will give you the FDA's current thinking.

Sam: As Samantha said, there's a lot to be learned from food defense. If you're looking for more resources on it, one of Food Online's last web chats was on food defense. If you want more information on that, feel free to browse our site for the transcript of the web chat, the unanswered questions. You can also view the entire web chat on food defense, if you're so inclined.

Moving on, our next question reads, “Other than being prepared and having a registration number, do we need to notify or send the plans to the FDA?”

Elizabeth: I'm assuming that the question is asking whether or not you need to send your food safety plans to the FDA. The answer is that you do not. Under the Preventive Controls rule, the FDA does not have remote records access; the inspections are conducted at the facility. The FDA will review those records there. They do have authority, under the regulation, to copy your record, but you do not need to send your records in to the FDA.

There's a slight difference, in respect to FSVP. The FDA does have remote record access under that rule and can request that you send your records into their agency for review. You will receive and actual request for that, there's no publication that at this point in time you affirmatively send in your records.