A Kellogg’s cereal manufacturer was recently issued an official FDA Warning Letter, which cites a number of food safety infractions linked to consumer illnesses reported by the Centers for Disease Control and Prevention (CDC). Kerry, Inc., the company that manufactures Honey Smacks, underwent an inspection at its Gridley, IL, facility after an outbreak of connected Salmonella infections spurred a voluntary product recall from Kellogg Co. As a result of the inspection, FDA investigators identified “serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.”
For food and beverage brands across the industry, there’s a great deal to be learned from the Kellogg’s incident. This article breaks down the specifics surrounding Kerry, Inc.’s food safety violations, the FDA’s official 483(b) notice and how you can apply these insights to safeguard your own company, reduce recall risk and improve food quality.
What Happened, and Why?
In May, the FDA learned about a cluster of Salmonella Mbandaka illnesses that emerged in multiple states. People infected with Salmonella often develop diarrhea, fever and abdominal cramps for several days. If severe enough, the illness can require hospitalization, and the infection may spread from the intestines to the bloodstream, necessitating treatment with antibiotics.
The Salmonella outbreak spurred a joint investigation between the FDA, CDC and state partners to identify the cause. Information collected during this time pointed to Kellogg’s Honey Smacks cereal as a possible source of the outbreak. After being alerted to the connection, Kellogg Co. voluntarily recalled the product, and the FDA moved forward with an inspection of the contract manufacturer’s facility.
The effort turned up evidence that a number of positive Salmonella samples from various areas of the production facility had been repeatedly ignored by the manufacturer, with no corrective actions implemented or reanalysis performed. In response, Kerry, Inc. was issued a 483(b) Warning Letter from the FDA. By the time a full investigation of the consumer illness outbreak was complete, the CDC had reported a total of 135 infected people from 36 states, including 34 hospitalizations.
What Did the 483(b) Warning Say?
The FDA Warning Letter outlined multiple serious compliance violations that occurred at the manufacturing facility. Here are some of the highlights:
- Between September 29, 2016 and May 16, 2018, you repeatedly found Salmonella throughout your facility, including in cereal production rooms.
- During this time period, you had 81 positive Salmonella environmental samples and 32 positive Salmonella vector samples (samples taken in response to finding a positive on routine testing), including four Salmonella (b)(4) samples in the cereal coating room (Line (b)(4)) and one Salmonella (b)(4) sample in the cereal (b)(4) room (Line (b)(4)).
- Further, you had repeated findings of other Salmonella species in some production lines and rooms used for the manufacture of cereal.
- These repeated findings of Salmonella in your environment should have resulted in a reanalysis of your food safety plan as required by 21 CFR § 117.170(b)(4) and the identification of contamination of RTE cereal with environmental pathogens as a hazard requiring a preventive control (i.e., sanitation preventive control).
What Major Mistakes Were Made?
You might assume that the primary fault here was finding positive Salmonella samples. But, in reality, that’s not the crux of it. Uncovering positive testing samples in any production facility is not a matter of “if,” but rather “when.” Even with the best laid food safety plans, positives are inevitable because no food production process is perfect.
What really determines success or failure in complying with government food safety regulations are the preventive measures a manufacturer has in place and, more specifically, how the team RESPONDS to positive samples when they arise.
The 483(b) Warning Letter issued to Kerry, Inc. stated:
- “Your hazard analysis did not identify a known or reasonably foreseeable hazard for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control…”
- “…you did not identify and implement sanitation controls adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen Salmonella as required by 21 CFR §§ 117.135(a)(1) and (c)(3).”
- “You did not implement written corrective action procedures that must be taken if preventive controls are not properly implemented to comply with 21 CFR 117.150(a)(1) and (d). Specifically,
- a) You did not implement your sanitation corrective action procedure, (b)(4). Section 4.1 of this procedure defines corrective actions as “steps taken to remove the root cause(s) of an existing nonconformity or undesirable situation.” Section 5.1.9 requires that a “Corrective Action/Preventive Action (CAPA) must be determined” for “any other significant event affecting food safety or quality.” Further, section 5.4 requires that “[t]he root cause analysis (RCA) must be thoroughly documented,” and section 5.5 requires that “[a]ll corrective . . . actions must be thoroughly documented and based on the results of the RCA.” However, you did not conduct and document a root cause analysis for the persistent findings of Salmonella in your facility during the time period of September 29, 2016 to May 16, 2018.
- b) You did not fully implement your sanitation corrective action procedure as specified in (b)(4). Section 18.104.22.168 require that after a positive pathogen result in zones 2, 3, or 4, “[a] response team must be formed to assess the result with the goal of defining a root cause and corrective action.” Your facility completed an “Environmental Investigation Report” for each positive pathogen sample you found; however, there is no documentation that you formed a response team to determine the root cause and corrective actions necessary to prevent the routine reoccurrence of Salmonella throughout your facility during the time period of September 29, 2016 to May 16, 2018.”
- “You did not verify that your sanitation preventive controls are consistently implemented and are effectively and significantly minimizing or preventing a hazard with environmental monitoring as required by 21 CFR 117.165(a).”
Due to these infractions, the FDA was authorized to assess and collect fees to cover their costs for certain activities. The letter also ordered the manufacturer to take prompt action (15 days) to correct the violations and document these corrections, or risk regulatory action by the FDA, including seizure and injunction.
How Can You Head Off Litigation Due to FDA Inspections?
This story of regulatory noncompliance exhibited by the Kellogg’s Honey Smacks manufacturer is a cautionary tale. If your organization is found to be in violation of any compliance mandates, the FDA or USDA may consider legal actions like:
- Initiating a seizure or injunction
- Implementing administrative detention to gain control of adulterated or misbranded products
- Suspending the facility’s food registration to prevent shipments
- Incurring criminal fines
You can also be sued by a sickened consumer on the basis of a contaminated or unsafe product, or you might face a class-action lawsuit. The damage caused by these outcomes bleeds out further than the results themselves. It can affect your brand reputation, your profitability and your long-term success.
The good news is that prevention of these consequences is completely within your control when you focus on these two critical steps:
- Implement a corrective action procedure/plan. A dynamic and thorough HACCP program is absolutely critical to minimizing your manufacturing company’s food safety risk. One of HACCP’s major principles is to adopt a robust corrective action process that identifies the root cause of any non-conformances in your production process and remediates it to prevent future occurrence. Whenever a food safety failure is uncovered, it is essential to take swift action to correct it, learn from it and revise your procedures accordingly.
- Document everything. Without thorough, accurate, organized and accessible documentation, you can’t protect your company from the penalties of regulatory noncompliance. What level of automation and transparency do you have to ensure that all actions and data points are being properly documented? With an automated system that features intense visibility and dynamic management controls, your team is equipped to meet compliance standards and minimize the risk of food safety liabilities.
You have an obligation to ensure the safety and quality of your food in order to prevent infection outbreaks and consumer illnesses. Meeting that responsibility head on is not only possible, but also simpler and more efficient when you leverage an innovative technology solution like CONTROL-PRO.
Learn about the valuable role food safety software plays in solving corrective action challenges, minimizing recall risk and safeguarding your brand from noncompliance nightmares. Download your free kit now.