On January 24, 2023, the Missouri Department of Health and Human Services alerted the US Food and Drug Administration (FDA) to a possible case of Clostridium botulinum in an infant.
Although primarily breastfed, the infant had also been fed some packaged refrigerated baby food on or around January 7th (pumpkin) and January 11th (broccoli). On January 18th, the infant began to show symptoms of botulism.
By January 22nd, the infant had been hospitalized, and treatment with an anti-toxin was initiated.
The treatment was successful and the infant survived.
The baby food was manufactured by Oceanitan, LLC, a contract manufacturer of baby food products located in Los Angeles, California.
The investigation
On February 3rd, a Missouri health inspector collected samples of the product from the infant’s home and submitted them to the FDA for analysis.
On February 16th, with the lab analysis underway, the FDA began an in-depth inspection of Oceanitan’s manufacturing facility—an inspection that would continue into early April.
The inspection revealed multiple, serious violations of various federal standards (“rules”) for safe manufacture of food products. These violations included:
- Lack of preventive controls for bacterial growth and/or toxin formation by Clostridium botulinum in the finished, packaged ready-to-eat products
- Use of uncalibrated and inaccurate thermometers to measure storage temperatures
- Exposure of cooked ingredients and products to potential environmental contamination during cooling, production, and packaging
- Lack of an environmental monitoring program
- Inadequate sanitation controls procedures
- Lack of a validation study to support cooking parameters specified in the written Process Control document
- Dripping water, exposed rust, and peeling paint in various areas of the manufacturing facility
While the inspection was still in progress, the FDA laboratory completed its analysis. The products collected by the Missouri inspector from the home of the sick infant were contaminated with both a non-toxin strain of Clostridium botulinum and a strain of Clostridium beijerinckii.
Although both of these strains were non-pathogenic, they represented clear evidence that a toxin-producing strain of Clostridium botulinum would have been fully capable of growing in the baby food. The lab also reported that the pH and water activity of these products were well within the range to promote growth of the pathogen.
The follow-up
In keeping with the agency’s standard operating practice, the FDA investigator met with company management on April 6th at the completion of the inspection to make a formal presentation of FDA Form 483 (Inspectional Observations) and review the documented violations.
On April 27th, Oceanitan’s Chief Executive Officer, Nelson Lee, responded in writing to the list of observations. He informed the FDA that the company had purchased calibrated temperature data monitors for its coolers, contracted a third-party lab to initiate an environmental monitoring program, updated its sanitation program, cleaned and repaired ceilings and walls, and initiated steps to have other repairs performed by an outside contractor.
After reviewing the company’s response, the FDA issued a Warning Letter on September 7, 2023. In its letter, the agency noted that Oceanitan had not taken steps to update its hazard analysis or implement written procedures for monitoring a preventive control. Nor did the company provide a validation study for its process control parameters.
The FDA gave Oceanitan fifteen working days from receipt of the letter to notify the agency in writing of the steps it was taking to correct the remaining violatiosn and prevent a recurrence, and also advised the company that the agency would be conducting a follow-up inspection to determine Oceanitan’s compliance with the requirements of the Federal Food, Drug, and Cosmetic Act and its asssociated regulations.
Botulism—Infant and otherwise
Botulism is not a common occurrence.
In 2019, the most recent year for which data are posted on its website, the US Centers for Disease Control and Prevention (CDC) reported 152 cases of infant botulism and just 21 cases of foodborne botulism.
That same year, the CDC logged 58,371 non-typhoidal Salmonella reports and 16,939 reports of shiga toxin-producing E. coli.
Infant botulism can be associated with consumption of honey that is contaminated with spores of Clostridium botulinum. In fact, in Canada, raw honey is the only food that has been specifically linked to infant botulism.
In foodborne botulism, individuals become ill from eating a food that contains pre-formed toxin. But in the case of infants, it’s not necessary for the toxin to be present in the food. Clostridium botulinum spores can multiply and produce their deadly toxin in the baby’s intestine.
The take-aways
The baby food products manufactured under contract by Oceanitan were neither commercially sterile nor shelf-stable.
The products were sold as refrigerated, “ready-to-eat” baby foods.
Information on the brand(s) of baby food products manufactured by Oceanitan was redacted from the documents obtained by eFoodAlert under the Freedom of Information Act, as this information is considered to be proprietary.
The manufacturing process consisted of cooking the individual ingredients before they were mixed and puréed. There was no second “kill” step either before or after the products were filled into their 4-ounce plastic jars. And there were serious flaws in the company’s hazard analysis, environmental monitoring, and facility maintenance.
By neglecting fundamental principles of safe food manufacture, the company and its commercial customers put a vulnerable population at risk.
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