What happened
Original notice title
Hearthy Foods, Inc. MARCS-CMS 712415, February 10, 2026
From the archived source record
Based on inspectional findings and review of the product labels collected during the inspection, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Adulterated Conventional Foods During the inspection, the FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Based on FDA’s inspectional findings, we determined your ready-to-eat (“RTE”) Whey Protein Isolate processed in your facility is adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)], in that it was prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth or may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. 331(uu)]. Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C): 1. You did not identify and evaluate recontamination with environmental pathogens (e.g., Salmonella and Listeria monocytogenes) as a known or reasonably foreseeable hazard to determine whether it requires a preventive control, to comply with 21 CFR 117.130(c)(1)(ii). A knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control (e.g., sanitation controls). It is unclear if your sanitation procedure includes equipment (e.g. hopper on powder-dispensing equipment, storage bins) and the processing room where the RTE Whey Protein Isolate is exposed and at risk of contamination with pathogens.
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
- e464af00fabe
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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