EFOOD ALERT

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.”