6/20/2023 0 Comments Bio dim supplementFor a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Section 743 of the Act authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection- related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act). 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”) United States v. To the extent that a another firm manufactures dietary supplements on your behalf as a contract manufacturer that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution. Although a firm may contract out certain dietary supplement manufacturing operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Additionally, you do not perform quality control functions, such as reviewing documentation from the manufacturers with whom you contract with relating to how your dietary supplement products are manufactured and whether they conform to established specifications. However, there was no evidence of quality control approving or rejecting any relabeling of the packaged and labeled dietary supplement, as required by 21 CFR 111.127(g), nor is there evidence of quality control approval for release, or rejecting of the relabeled dietary supplement for distribution, as required by 21 CFR 111.127(h). Specifically, during the inspection it was observed that your firm had relabeled case packaging of dietary supplement products because the contract manufacturer had not properly labeled the cases. 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, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Mark Hincher, President, on the Form FDA 483 Inspectional Observations issued, at the conclusion of our inspection.ġ. The inspectional observations were provided to Mr. These violations cause your dietary supplement products 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 insanitary conditions that do not meet CGMP regulation for dietary supplements. Food and Drug Administration (FDA) inspected your warehouse and distribution center located at 1875 Walnut Hill Lane, Suite 100, Irving, Texas where your dietary supplement products are received, stored, and distributed under the name, BioTE Medical. The inspection revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). From Octothrough November 4, 2016, the U.S.
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