There were two companies in cities associated with Denton County that received FDA citations as a result of two inspections conducted in the county in March, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 60% decrease from the number of companies cited in the previous month.
The citations in the county were ‘The device history record does not demonstrate that the device was manufactured in accordance with 21 CFR 820’ and ‘Document control procedures have not been adequately established’.
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 |
|---|---|---|---|
| Metro Optics, Inc. | Devices | 03/17/2025 | Procedures not adequately established or maintained |
| iVu Imaging Corporation | Devices | 03/05/2025 | DHR content |
