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Talk to a SpecialistTalk to a SpecialistHealthtex Distributors, Inc., a dietary supplement distributor in Miami, Florida, violated Current Good Manufacturing Practice (CGMP) regulations under 21 CFR Part 111 during FDA's inspection in January and February 2023, resulting in adulterated products that were prepared, packed, or held under non-compliant conditions. The company also committed serious labeling violations under 21 CFR Part 101 for its Dr. Sana Cod Liver Oil and Dr. Sana Orange Blossom Flower Water products, rendering them misbranded. The FDA's inspection uncovered these violations across the company's warehouse and distribution operations, and the company's February 2023 response to the inspectional observations did not resolve the noted deficiencies.