What happened
Original notice title
CC Pollen Company MARCS-CMS 714784, January 09, 2026
From the archived source record
Based on inspectional findings, we identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. We received your written response to those observations on April 25, 2025 and discuss your corrective actions below in relation to each of the noted violations, where applicable. Adulterated Dietary Supplements The inspection of your facility on April 7, 2025 through April 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). These violations cause the dietary supplements, Bee Pollen Granules and Royal Jelly capsules manufactured at your facility to be adulterated within the meaning of 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. We have reviewed your response dated 4/25/25, in which you state that you will be training quality control personnel concerning the need to review all documents to ensure there are no missing signatures or dates before items are released. Misbranded Dietary Supplements In addition, we reviewed your product labels collected during the inspection and have determined the Bee Pollen Granules and Royal Jelly capsules products product you manufacture/distribute are misbranded under section 403 of the Act [21 U.S.C. 343] because they do not comply with the labeling requirements for dietary supplements. Your firm’s CC Pollen Royal Jelly capsules product is misbranded within the meaning of section 403(q)(1)(A) because the serving size declared on the label is incorrect.
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
- ffc2fca8e09b
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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