What happened
Original notice title
Imu-Tek Animal Health, Incorporated MARCS-CMS 724610, June 05, 2026
From the archived source record
Based on inspectional findings and our review of your website, www.Imutek.com, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs FDA reviewed your website at the Internet address www.imutek.com in April 2026 and has determined that you take orders there for the products Colostrom-5 Capsules and Colostrom-5 Powder. Misbranded Drugs A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, Colostrom-5 Capsules and Colostrom-5 Powder fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)]. Adulterated Dietary Supplements The inspection of your facility from October 6 through October 14, 2025, identified serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). Thus, in addition to being unapproved new drugs and misbranded drugs, your Colostrum-5 Capsules and Colostrum-5 Powder are also adulterated dietary supplements under section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Your significant violations of the CGMP requirements are as follows: 1. Your quality control personnel failed to reject a component or dietary supplement or approve a treatment, in-process adjustment, or reprocessing when a deviation or unanticipated occurrence took place during the production and in-process control system that resulted in, or could lead to adulteration of, a component or dietary supplement, as required by 21 CFR 111.113(b)(1).
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 7b1c75c33781
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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