It’s not a question of if, but when, officials with the Food and Drug Administration will show up at any given food company for an unannounced inspection, with any violations outlined in a Form 483 that is handed off to company representatives as inspectors head out the door. While the Form 483 itself is essentially only a notice outlining breaches of regulations, consequences from an incorrect response can lead to criminal charges and shuttered doors.
A quick look at FDA’s FY 2016 Inspectional Observation Summaries reveals a cool 2,196 Form 483 reports were hand delivered to food companies from October 2015 through the end of September 2016. Shawn K. Stevens, a lawyer specializing in food safety and the founder of Food Industry Counsel LLC, says to expect that tally to reach more than 2,500 during 2017 as the Food Safety Modernization Act regulations come into effect.
There are several new enforcement priorities the FDA is cracking down on, according to Stevens, which include food safety records evaluation, microbial sampling for pathogenic contamination, and broader investigations into food companies when their products are found to have caused human illness. However, he offers insight into the three-point checklist FDA can be expected to follow during its unannounced inspections.
Rough welds, cracks on surfaces and conveyer belts, holes in the roof, and condensation near exposed products are just a small sample of the types of physical compromises FDA investigators will be looking for during their visual inspection of production, packing, distribution or storage locations. Such inspections tend to last about a day as FDA investigators get oriented with the facility and determine the amount and locations of microbial samples they plan to take, Stevens said.
“The things FDA is concerned about most are microorganisms that can make people sick. As a result, when FDA comes into the facility, it’s going to be extremely intense on finding conditions that allow bacteria to grow,” Stevens said. “This includes any conditions which allow water or moisture to enter or accumulate in the facility or remain unchecked.”
This portion of an inspection should not be taken lightly, Stevens said. In 1975, a U.S. Supreme Court landmark case, United States v. Park, ruled that John Park, CEO of Acme Markets Inc., was personally and criminally liable for his company’s failings to maintain a sanitary facility after rodent droppings were discovered during an FDA inspection and not found to be rectified in a follow up inspection three months later.
“The case took place in 1975, but the doctrine is still being used by FDA today,” Stevens said. “FDA has used observations of seemingly subtle violations such as evidence of rodent droppings near packaged products to support criminal misdemeanor chargers against company employees. Any visual observation noted by FDA should be taken very seriously.”
Once the visual inspection is complete, FDA investigators will usually go on the search for pathogens via microbiological sampling. As preventive controls for food safety tighten with FSMA, this portion of the investigations, which Stevens refers to as the “swab-a-thon” takes center stage. And while each case is different, Stevens has seen an average of 100 to 150 swab samples collected by FDA during one to two days with his clients.
Extensive sampling will be conducted in so-called Zone 1, Zone 2, Zone 3 and Zone 4 of food facilities. The zones refer to areas of facilities such as food production areas in Zone 1 and non-production areas such as employee locker rooms in Zone 4. Any pathogens found will be compared to the Center for Disease Control and Protection’s PulseNet database to see if a match is found to any of the more than 1 million human foodborne illness isolates collected in recent years.
“The agency will be intent, in most cases, in looking in the most difficult to clean and difficult to reach places where bacteria like Listeria and Salmonella like to hide,” he said. “I have seen inspections where the FDA swabbed the buttons on the coke machine in the employee break room – everything is fair game.”
If a human illness pathogen is found, the FDA can trigger a recall of any affected products. Because it can take three to four days for microbial samples to be processed, Stevens recommends a company pull anything out of production that investigators sample until results are available.
“In many cases, the agency will sample the company’s incoming raw materials,” he said. “In all cases, FDA will sample Zone 1 contact surfaces through production equipment and finished products.”
Perhaps the most crucial piece of advice Stevens has to offer a company undergoing an inspection is to not take their own samples alongside FDA investigators.
“I don’t recommend taking companion samples under any circumstances. By taking companions samples, we double the chances through lab error or otherwise, for there to be a positive. I am aware of cases where FDA’s samples were all negative and a company’s companion samples ended up testing positive, which is always uncomfortable,” he said.
“If the FDA had one positive and we had 100 negatives, our result wouldn’t change their result. A FDA positive is a positive is a positive – so really there is no benefit.”
On that note, he also recommends companies develop a microbiological sample retain policy requiring labs to discard any testing material and samples within 24 hours of being tested for its own food safety auditing program. While labs and food companies are required to maintain the final results of any testing for FDA review, the testing samples themselves need not be kept.
“If a company or its laboratory preserves retained samples after product is manufactured or tested, FDA may try to gain access to those samples and test them as part of the swab-a-thon,” Stevens said.
Mandated by FSMA, companies are required to keep at least two years of records on file to provide to investigators. Stevens said FDA will be closely analyze records and written food safety plans to make sure they are in compliance.
“In most cases, the FDA investigators will want to methodically review at least up to three months of production records,” Stevens said. “All companies will need to make sure they have the records readily available, and that their programs and monitoring documents have the look and feel FDA will expect to see.”
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