There was one company in a city associated with Boulder County that received FDA citations as a result of one inspection conducted in the county in September, according to the U.S. Food and Drug Administration (FDA).
No companies were cited in the previous month.
The citations in the county include:
- You did not use equipment or utensils that can be adequately cleaned and that are properly maintained.
- You did not provide adequate documentation of your basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that the specifications are met for strength and limits on contamination.
- You did not establish product specifications for limits on contamination.
The company cited should take a voluntary action to correct its 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 |
|---|---|---|---|
| Kroeger Herb Products Company, Incorporated | Food and Cosmetics | 09/08/2025 | Equipment – design – appropriate and suitable |
| Kroeger Herb Products Company, Incorporated | Food and Cosmetics | 09/08/2025 | Specifications identity, purity strength, composition |
| Kroeger Herb Products Company, Incorporated | Food and Cosmetics | 09/08/2025 | Specifications – finished dietary supplement |
| Kroeger Herb Products Company, Incorporated | Food and Cosmetics | 09/08/2025 | Specifications met – verify; production, process control |
| Kroeger Herb Products Company, Incorporated | Food and Cosmetics | 09/08/2025 | Quality control – processes, specifications, written procedures |
| Kroeger Herb Products Company, Incorporated | Food and Cosmetics | 09/08/2025 | Quality control – required operations |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
