There were two companies in cities associated with Benton 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 unchanged from the number of companies cited in the previous year.
The citations in the county include:
- Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation and informed consent.
- You did not make and keep documentation of your qualification of a supplier.
- Your quality control operations did not include determining whether each finished batch conforms to established product specifications.
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 |
|---|---|---|---|
| Fayz A. Hudefi, M.D. | Drugs | 09/20/2024 | Case history records- inadequate or inadequate |
| Houston Nutraceuticals, Inc. | Food and Cosmetics | 02/01/2024 | Documentation – supplier qualification |
| Houston Nutraceuticals, Inc. | Food and Cosmetics | 02/01/2024 | Quality control operations – finished batch, specifications |
| Houston Nutraceuticals, Inc. | Food and Cosmetics | 02/01/2024 | Criteria for establishing specifications |
