Oceanitan, Inc. – FDA Warning Letter, Apr 6, 2023

The FDA inspected a food manufacturing facility at 2937 E Pico Blvd, Los Angeles, CA, from February 16, 2023, to April 6, 2023, following a consumer complaint involving infant botulism. The facility contract manufactured refrigerated ready-to-eat (RTE) baby food products in reduced oxygen packaging (ROP).

The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (21 CFR Part 117), leading to the determination that the products are adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, significant violations of food labeling regulations (21 CFR Part 101) were found, causing products to be misbranded under section 403 of the Act.

Key violations include: 1. **Hazard Analysis Deficiencies (21 CFR Part 117, Subpart C):** * Failure to identify and evaluate bacterial growth and/or toxin formation (specifically *Clostridium botulinum*) due to ROP during refrigerated storage. The firm's stated maximum temperature of (b)(4)°F is insufficient, as nonproteolytic *C. botulinum* can grow at (b)(4)°F. Cooler temperatures were observed above acceptable limits, and non