There were two companies in a city associated with Boone County that received FDA citations as a result of two inspections conducted in the county throughout 2024, 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 year.
The citations in the county include:
- You did not ensure individuals were qualified to perform their assigned duties and have records documenting food hygiene and food safety training.
- The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
- Potential suppliers were not evaluated and selected based on their ability to meet specified requirements.
Both 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 quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| B. Happy Peanut Butter | Food and Cosmetics | 06/05/2024 | Qualifications of individuals |
| Vocare, Inc. | Devices | 07/25/2024 | Design history file |
| Vocare, Inc. | Devices | 07/25/2024 | Evaluation and Selection, Suppliers, Contractors, etc. |
