The results of any testing or examination performed during the batch production, or a cross-reference to such results.The actual results obtained during any monitoring operation.A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing.The unique identifier that you assigned to each component (or, when applicable, to a product that you receive from a supplier for packaging or labeling as a dietary supplement), packaging, and label used.The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a crossâreference to records, such as individual equipment logs, where this information is retained.In addition, for the products that are manufactured, packaged, and labeled by your contract manufacturer (including Diabalance Herbal Blood Sugar, Black Cumin Seed Oil Softgel, and Quick Slim with pure Hoodia Gordonii) you do not perform quality control functions, such as reviewing and approving the documentation to determine whether the received product meets the specifications that you established under 111.70(f) and, when a specification established in accordance with 111.70 is not met, rejecting the component, dietary supplement, package or label unless quality control personnel approve a treatment, an in-process adjustment, or reprocessing, as permitted in 111.77. Specifically, you acknowledged to our investigators that you have not established any written procedures for quality control operations. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103 and 111.140(b)(1).O Corrective action plans for use when a specification is not met. These violations cause your dietary supplement products, including but not limited to Diabalance Herbal Blood Sugar Balance Tablets, Quick Slim with pure Hoodia Gordonii Capsules, BHealthy Black Seed Bitter Melon 90 Veggie Capsules, Black Seed w/ Olive Leaf/Garlic Capsules, Black Seed Honey Booster, Sweet Excitement Her Honey, Revive Honey Herbal Elixir, Flax Seed Oil, Black Seed Oil, and Black Cumin Seed Oil, to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements found under 21 CFR Part 111. Based on our inspection, we identified significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Food and Drug Administration conducted an inspection of your facility located at 17 Oberfest Street, Liberty, NY 12754 from Augthrough September 21, 2016.
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