There was one company in a city associated with Coconino County that received FDA citations as a result of one inspection conducted in the county over the second quarter of 2025, according to reports from the U.S. Food and Drug Administration (FDA).
This is an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- For component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary supplement are met and limits on contamination to ensure the quality of the dietary supplement.
- You did not establish product specifications for identity, purity, strength, composition and limits on contamination.
- You did not qualify a supplier of a component by establishing the reliability of the supplier’s certificate of analysis through confirmation of the results of their tests or examinations.
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 quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Ambaya Gold Health Products, LLC | Food and Cosmetics | 05/23/2025 | Specifications – components |
| Ambaya Gold Health Products, LLC | Food and Cosmetics | 05/23/2025 | Specifications – finished dietary supplement |
| Ambaya Gold Health Products, LLC | Food and Cosmetics | 05/23/2025 | Component – qualify supplier |
| Ambaya Gold Health Products, LLC | Food and Cosmetics | 05/23/2025 | Master manufacturing record – record requirements |
| Ambaya Gold Health Products, LLC | Food and Cosmetics | 05/23/2025 | Batch record – complete |
| Ambaya Gold Health Products, LLC | Food and Cosmetics | 05/23/2025 | Batch record – required information |


