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OFP Ingredients LLC, a dry milk powder processor, was warned for serious violations of Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls regulations. FDA inspections of the facility in May-July 2021 identified violations of 21 CFR Part 117 and detected Salmonella enterica serovar Cubana, a human pathogen, in environmental samples from processing areas near food-contact surfaces. The agency determined that the ready-to-eat dry milk powder was adulterated because it was prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health. The company failed to comply with preventive controls provisions required under the CGMP & PC rule.