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Breadbox Co., a bakery manufacturer in Santa Fe Springs, California, was cited for serious violations of Current Good Manufacturing Practice (CGMP) and preventive controls regulations for their ready-to-eat bakery products, which were determined to be adulterated due to preparation under insanitary conditions that may have led to contamination. FDA investigators found that the company failed to prepare and implement a required food safety plan overseen by preventive controls qualified individuals (PCQIs), in violation of 21 CFR Part 117. The facility was inspected from May 10 through June 7, 2024, and the company had not provided a written response to the inspectional observations documented on the FDA-483 form at the time the warning letter was issued.