There was one company in a city associated with Warren County that received FDA citations as a result of one inspection 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:
- The design history file does not demonstrate that the design was developed following the approved design plan.
- Procedures to control environmental conditions have not been adequately established.
- Software used as part of production and the quality system has not been adequately validated for its intended use according to an established protocol.
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 |
|---|---|---|---|
| Visionary Optics, LLC | Devices | 05/17/2024 | Design history file |
| Visionary Optics, LLC | Devices | 05/17/2024 | Environmental control Lack of or inadequate procedures |
| Visionary Optics, LLC | Devices | 05/17/2024 | Software validation for automated processes |
| Visionary Optics, LLC | Devices | 05/17/2024 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| Visionary Optics, LLC | Devices | 05/17/2024 | Lack of or inadequate procedures |
| Visionary Optics, LLC | Devices | 05/17/2024 | Evaluation, timeliness, identification |
