What the FDA Inspects at a Food Production Facility, and How to Keep Your Business Compliant
As a business owner or manager, you need to ensure that your food production facility is compliant with FDA regulations. After all, compliance prevents penalties and ensures that your facility can continue to operate.
You can find the FDA guidelines on its website, but that information includes legalese and technical jargon. The following guide will fully answer your question, “What does the FDA inspect?” so you don’t have to search elsewhere. We will even give you the best advice for keeping your facility FDA-compliant.
FDA Guidelines for Food Production Facilities
The most important guidelines for food production facilities have to do with overall cleanliness. The FDA ensures that your facility has no cross-contamination or other potential issues. Specifically, you can expect an FDA facility inspection to include the following.
Food Safety Programs
Expect the FDA inspector to ask about your food safety programs. Inspectors will ask to see the documentation for these programs and verify the records, ensuring that your program meets the latest FSMA requirements.
An Overall Tour/Inspection
The first part of an FDA facility inspection will typically be an overall inspection of the facility. Plan on giving the inspector a tour of the processing areas, as well as every other relevant area of your facility.
Reviewing the Records
You can also expect the inspector to scrutinize your records. As mentioned, your records should include food safety programs and records for monitoring and verification.
The FDA is not entitled to review financial, pricing, sales, research, or personal data. For personal data, they can only ask for proof of appropriate training.
Microbiological Sampling
During the inspection, the FDA will collect a vast number of samples. Expect them to collect swabs from several areas of your facility, usually totaling about 100 to 200 swabs. These swabs will include samples from Zone 1 through Zone 4 environments, outgoing products, and incoming ingredients.
The organization will then test every sample for potential contamination, including pathogens. If the results show high levels of certain pathogens, including salmonella or listeria monocytogenes, expect the FDA to require you to issue a recall. The results of the biological samples from your facility will also be compared to the DNA fingerprints of other pathogens in the FDA’s system.
The Importance of FDA Compliance
When it comes to food processing facilities, you can expect the FDA to do routine inspections due to health and safety reasons. The consequences of not passing the inspection can be catastrophic, potentially even closing down your business permanently. Of course, if you take steps to remain compliant at all times, you need not be worried.
That said, you should recognize the risks that come with failing the inspection. To start, non-compliance can involve official penalties and fines that may hurt your business. Fines will have an obvious financial impact on your company. But other penalties, such as recalls or temporary facility closures, can also become incredibly costly.
Failing an inspection can also damage your company’s reputation significantly. Depending on the extent of the damage to your reputation, you may not be able to attract enough customers. At the very least, you will have to work much harder to attract clients, reassuring them that you have addressed the FDA’s concerns.
How to Prepare for an FDA Inspection
Once you know that the answer to “Does the FDA inspect food processing facilities?” is yes, you may wonder how to prepare. The good news is that you should receive notice of an upcoming inspection. This will give you time to gather documents and make other preparations. Don’t expect to have enough warning to make any drastic changes, as that will defeat the purpose of the inspection.
Start by getting in the habit of following the FDA guidelines and best practices. These are highly focused on sanitation, so you must have a detailed cleaning and maintenance plan in place. Consider outsourcing facility cleaning to a company familiar with FDA requirements. Remember that in addition to general facility cleaning, you must have food disinfection protocols in place.
Gather an Inspection Response Team
Creating an inspection response team is one of the first things to put on your FDA facility inspection checklist. This team will consist of people who will be responsible for gathering relevant documents. It will also include at least two people to accompany the FDA inspector. One of these individuals should act as a guide for the inspector, while the other should be a scribe and record everything that transpires. Documenting the inspection will be useful for your records and can even help you prepare for future inspections.
Have Someone Accompany the Inspector at All Times
As mentioned, someone should serve as a guide for the FDA inspector. Importantly, if that person has to leave the FDA inspector for some reason, another person should take their place. Never leave the FDA inspector unattended. This could reflect poorly on your facility and present extra opportunities for them to find deficiencies.
If the inspector is alone, you also lose knowledge of their inspection. You won’t know what areas of the facility they see or be able to ask questions about their procedures. In fact, the FDA encourages you to ask questions if you aren’t sure why the inspector is taking a certain action.
Set Up a Space for the Inspector
While you won’t have enough notice to deep clean your facility before the inspector arrives, you will have enough time to set up a space for them to work. Clearing out a conference room or office will put the inspector in a better mood, so make sure you include it on your FDA facility inspection checklist.
Gather Documents
One of the most important roles of your inspection response team will be gathering all the documents that the FDA inspector will likely request. Make it a habit to organize your documents regularly, so the necessary paperwork should be easy to find. It may help to organize these documents in chronological order. You may even want to create charts or graphs.
Correct Deficiencies as Soon as Possible
Even with the best preparation and policies, FDA inspectors will still find areas for improvement within the facilities they inspect. These will be noted on Form 483, which you can see a copy of. You will also be able to discuss the findings with the inspector. Minor issues are unlikely to result in penalties or fines if you take care of them quickly.
Start correcting any noted deficiencies as swiftly as possible. In some cases, you may even be able to start correcting them while the inspector is still present. Do so whenever possible, as this indicates your willingness to comply. Also, make sure to document all the corrections you make.
Get Inspection Support From Your Contractor
The best way to prepare for an FDA facility inspection is to combine good regular practices with support from a contractor. For example, Kaloutas provides inspection preparation and support. These services help keep you FDA-compliant, safe, and productive.
Let Kaloutas help keep your facility compliant with the most recent FDA guidelines.
