Baby food maker linked to infant botulism complaint

In February and March 2023, US Food and Drug Administration (FDA) found Clostridium botulinum (a non-toxic strain) and Clostridium beijerinckii in previously unopened plastic jars of ready-to-eat baby food products manufactured by Oceanitan, Inc. (Los Angeles, CA) after a consumer reported a case of infant botulism.

Oceanitan manufactured the baby foods under contract for a third party. There was no product recall, and the name of the third party was not released.

The FDA responded to the consumer complaint by initiating an inspection of Oceanitan’s manufacturing facility, located at 2937 E Pico Blvd, Los Angeles, CA.

During the course of a seven-week investigation, FDA inspectors identified multiple serious violations of federal regulations, including failure to identify known or reasonably foreseeable hazards, inadequate temperature control, insanitary conditions, and misbranding (ie., labeling violations).

According to information contained in a Warning Letter issued on September 7, 2023, and posted on the FDA website on September 29th, the baby food products “…do not receive a treatment lethal to nonproteolytic or proteolytic C. botulinum before or after packaging, and their formulation does not control for the growth and/or toxin formation of C. botulinum.”

Furthermore, management’s reliance on uncalibrated and inaccurate dial thermometers to monitor air temperature in the company’s coolers resulted in conditions that would have been able to support growth and toxin formation by Clostridium botulinum in the baby food products prior to shipment.

Inspectors also observed water dripping from the condenser unit in one of the coolers in close proximity to where jars of baby food were filled, and standing water on the floor where uncovered jars of food were stored.

On April 6, 2023, FDA inspectors issued a FDA Form 483, Inspectional Observations, listing all of the violations documented during the seven-week investigation.

The company responded in writing to the list of observations on April 27, 2023, describing the measures it had taken or planned to take to address the various deficiencies.

According to the FDA, the company’s planned actions were inadequate to address all of the indicated violations.

Oceanitan has been given fifteen working days from receipt of the Warning Letter to respond in writing to the FDA with details of the steps taken to address all outstanding issues or, if necessary, to provide a timeline for completion of its corrective measures.