This year, FDA will issue nearly 2,500 FDA Form 483s, and mail countless warning letters to food companies. Sometimes, even the most subtle food safety failures can cause FDA to threaten to shut your facility down. In the most recent examples involving producers of raw cookie dough, packaged ready-to-eat salads, seafood, hummus, and milk powder, routine FDA inspections turned nightmarish as the agency spent days sweeping through the facilities searching for violations. In each of these instances, the companies involved were required to halt production and invest substantial resources in food safety improvements. We can learn from each of these examples, and ensure the following scenario isn’t repeated when FDA visits us.
It all starts with an unannounced arrival in the lobby. A produce company is operating in full swing at its chopped bag salad plant when investigators with the Food and Drug Administration come calling for a random inspection. For the next two weeks, investigators’ eyes are on everything, pouring through records, food safety plans, collecting samples and making observations. When their evaluation is complete, a five-page document is handed over to the food company’s senior management with a summary of the inspection. This document, known formally as a FDA Form 483, notes three separate observations recorded during the investigation, highlighting issues with contamination of surfaces, floor and wall construction and a failure to conduct pest screening.
“Essentially, a Form 483 is like a police officer giving you a speeding ticket,” explains Shawn K. Stevens, food safety lawyer and founding member of Food Industry Counsel, LLC. “It outlines all the violations that the FDA investigators observed while inspecting your facility.”
But while the Form 483 itself is hand delivered in black and white, how the FDA handles the case after the inspection holds a few shades of grey, making it essential that food companies are on their A game before the FDA comes walking through its doors.
According to Stevens, the first step starts with food companies taking action to prevent violations that could lead to a Form 483 by conducting “smart sampling” for food safety pathogens rather than random sampling, with a “how can we catch ourselves in the wrong” mindset. In these cases, it may be beneficial to hire a third-party food safety consultant to run the company through a mock inspection to help identify and resolve any potential contamination issues before FDA arrives.
“Although many food companies test for pathogens, they are not always receiving an accurate picture of the microbial activity in their facilities because they’re sampling at the wrong times and in the wrong places,” says Stevens. “Sample in processing areas while they are producing product versus sampling immediately after sanitizing a surface, and then commit to conduct aggressive root source analysis to discover the original source of the contamination when positives are found.”
“Don’t get me wrong,” he adds. “We all like negatives, but if they aren’t really telling us anything they are worthless.”
The next step comes on the inevitable day FDA investigators walk through the doors without warning. By law, food companies are required to give officials reasonable access to facilities to complete the inspection, including what he refers to as a “swab-a-thon” when investigators collect samples for microbial testing.
“The inspection itself, including the swabbing, can last anywhere from a few days to a few weeks. Once the FDA has collected its samples, results will not typically be available for at least 3-4 days,” he explains. “This puts companies in a precarious and often uncomfortable position of having to determine whether to hold all their products or allow them to be shipped in commerce while they await the final results.”
Once the inspection is finished and the Form 483 is provided if any violations have occurred, it is essential the company mails a detailed written response to the FDA, providing explanation for how the violations were corrected. Failure to provide a response or sending an inadequate response can lead to the issuance of a warning letter from the FDA with threats to shut the company down.
“If the violations in the Form 483 are serious enough, and if the company fails to provide a written response, then in many cases, the FDA will issue a warning letter threatening to shut the company down. As a result, it is essential for any food company receiving a Form 483 to provide a written response to FDA typically within 15 business days. Doing so will decrease substantially the likelihood that FDA will feel that a warning letter is necessary,” says Stevens. “The most important thing a company can do is to take any alleged violation seriously, and show that it cares. The company can do this by immediately correcting any observed failures and then providing a detailed well thought-out response to each of the Form 483 violations.”
In some of the cases cited above, however, the responses provided by the companies targeted were insufficient. Thus, it is essential that every company faced with a Form 483 or warning letter obtain counsel to help prepare a response that will survive agency scrutiny. Although we will address the art of responding successfully to Form 483s and warning letters in a future piece, for our purposes here, we should learn from each of the examples cited above to avoid making the same mistakes before FDA arrives.
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