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Oceanitan, Inc., a Los Angeles-based contract manufacturer of refrigerated ready-to-eat baby food in reduced oxygen packaging, was cited for serious violations of Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventative Controls regulations. The FDA's February-April 2023 inspection, triggered by a consumer complaint involving infant botulism, found that the facility prepared, packed, or held products under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health, rendering the baby food products adulterated. Additionally, the company failed to comply with preventive controls provisions and violated food labeling regulations under 21 CFR Part 101, making the products misbranded.