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Talk to a SpecialistTalk to a SpecialistLone Star Botanicals Inc. was cited for manufacturing ready-to-eat seasoning blends under insanitary conditions in violation of Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventative Controls regulations (21 CFR Part 117), rendering the products adulterated and potentially contaminated with filth. The FDA inspection conducted April 17-21, 2023 also identified significant labeling violations under 21 CFR Part 101, with certain products making drug claims that were not properly substantiated, causing them to be misbranded. The facility's failure to implement required preventive controls and comply with food safety regulations violated both the CGMP & PC rule and the Federal Food, Drug, and Cosmetic Act.