There were five companies in cities associated with Larimer County that received FDA citations as a result of five inspections conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).
This is a 150% increase over the number of companies cited in the previous year.
Of the 25 citations issued, the most common citations include:
- You did not register and file Form FDA 2541 (food canning establishment registration) with FDA within 10 days after first engaging in the manufacture, processing and packaging of acidified foods.
- The certificate of analysis for a component does not include a description of the test or examination method(s) used, limits of the test or examination and actual results of the tests or examinations.
- Your master manufacturing record did not include all required information.
Most of the companies cited were involved in the Food and Cosmetics sector.
All of the companies cited should take voluntary actions to correct their managing operations.
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Brad Oldemeyer, M.D. | Devices | 06/06/2025 | Investigator’s subject records inadequate |
| CLVM, LLC | Food and Cosmetics | 08/01/2025 | Registration |
| CLVM, LLC | Food and Cosmetics | 08/01/2025 | Specifications – components |
| CLVM, LLC | Food and Cosmetics | 08/01/2025 | Specifications – finished dietary supplement |
| CLVM, LLC | Food and Cosmetics | 08/01/2025 | Component – certificate of analysis |
| CLVM, LLC | Food and Cosmetics | 08/01/2025 | Specifications met – verify; finished batch |
| CLVM, LLC | Food and Cosmetics | 08/01/2025 | Quality control – reject; specification not met |
| CLVM, LLC | Food and Cosmetics | 08/01/2025 | Quality control – batch, product specifications |
| CLVM, LLC | Food and Cosmetics | 08/01/2025 | Master manufacturing record – record requirements |
| CLVM, LLC | Food and Cosmetics | 08/01/2025 | Batch record – required information |
| CLVM, LLC | Food and Cosmetics | 08/01/2025 | Written procedures – establish; laboratory |
| CLVM, LLC | Food and Cosmetics | 08/01/2025 | Written procedures – follow; holding and distribution |
| CLVM, LLC | Food and Cosmetics | 08/01/2025 | Personnel |
| CLVM, LLC | Food and Cosmetics | 08/01/2025 | Scheduled process establishment |
| Pulpo | Food and Cosmetics | 08/07/2025 | Registration |
| Pulpo | Food and Cosmetics | 08/07/2025 | Specifications – components |
| Pulpo | Food and Cosmetics | 08/07/2025 | Component – certificate of analysis |
| Pulpo | Food and Cosmetics | 08/07/2025 | Tests, examinations – scientifically valid |
| Pulpo | Food and Cosmetics | 08/07/2025 | Master manufacturing record – record requirements |
| Pulpo | Food and Cosmetics | 08/07/2025 | Batch record – required information |
| Pulpo | Food and Cosmetics | 08/07/2025 | Personnel |
| Pulpo | Food and Cosmetics | 08/07/2025 | Scheduled process establishment |
| SourceOne Holdings, LLC | Food and Cosmetics | 05/29/2025 | Develop FSVP |
| UC Health Poudre Valley Hospital | Biologics | 06/05/2025 | Adverse reaction – fatality |
| UC Health Poudre Valley Hospital | Biologics | 06/05/2025 | Storage temps./agitation |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
