There were two companies in a city associated with Loudoun County that received FDA citations as a result of two inspections conducted in the county over the third quarter of 2025, according to the U.S. Food and Drug Administration (FDA).
This is a 100% increase over the number of companies cited in the previous quarter.
The citations in the county include:
- You did not follow written quality assurance procedures.
- You did not conduct an appropriate laboratory determination to ensure that each batch of a PET drug product conforms to specifications before final release.
- Risk analysis is inadequate.
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 and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Euclid Vision Corporation | Devices | 08/15/2025 | Design Validation – Risk analysis not performed/inadequate |
| Euclid Vision Corporation | Devices | 08/15/2025 | Lack of or inadequate final acceptance procedures |
| Euclid Vision Corporation | Devices | 08/15/2025 | Lack of or inadequate complaint procedures |
| Sofie Company | Drugs | 07/25/2025 | Written QA procedures established, followed |
| Sofie Company | Drugs | 07/25/2025 | Conform to specs prior to release |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
