Drugs

Multiple Dietary Supplement Violations at ForYou

An FDA 2/19-2/21 inspection at ForYou, Inc., Loris, SC, found significant violations of current good manufacturing practice (CGMP) regulations for dietary supplements, among other violations. A just-released 10/20 Warning Letter says several of the firm’s products are considered to be unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

The letter also says the firm’s products are adulterated “in that they have been prepared, packaged, or held under conditions that do not meet the CGMP regulation for dietary supplements.” Significant violations cited in the letter are:

failing 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;
failing to establish and follow written procedures for holding and distributing operations;
failing to establish and follow written procedures to fulfill the requirements that apply to the review and investigation of product complaints; and
failing to establish and follow written procedures to fulfill the requirements that apply to return dietary supplements, including the procedures for conducting a material review and making a disposition decision.

The letter also outlines reasons why several of the firm’s products are misbranded.

ForYou was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with related documentation and a schedule for completing the corrections.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome