There were two companies in cities associated with Warren 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).
No companies were cited in the previous quarter.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not fully followed.
- Written records are not always made of investigations into unexplained discrepancies.
- Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals.
The companies cited were involved in either Drugs or Food and Cosmetics sectors.
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 |
|---|---|---|---|
| Sabeef, LLC | Food and Cosmetics | 08/08/2025 | Hazard analysis biological, chemical, physical |
| Sabeef, LLC | Food and Cosmetics | 08/08/2025 | Document review entity’s hazard analysis |
| Sabeef, LLC | Food and Cosmetics | 08/08/2025 | Evaluation – performance, risk |
| Sabeef, LLC | Food and Cosmetics | 08/08/2025 | Approved supplier procedures – importer established |
| Sabeef, LLC | Food and Cosmetics | 08/08/2025 | Supplier verification – establish written procedures |
| Sabeef, LLC | Food and Cosmetics | 08/08/2025 | Verification activity assurance |
| Sabeef, LLC | Food and Cosmetics | 08/08/2025 | Verification activity frequency |
| Sabeef, LLC | Food and Cosmetics | 08/08/2025 | Verification activity before import, periodically |
| Surmasis Pharmaceutical, LLC | Drugs | 08/01/2025 | Procedures not in writing, fully followed |
| Surmasis Pharmaceutical, LLC | Drugs | 08/01/2025 | No written record of investigation |
| Surmasis Pharmaceutical, LLC | Drugs | 08/01/2025 | Management review – defined interval, sufficient frequency |
| Surmasis Pharmaceutical, LLC | Drugs | 08/01/2025 | Quality plan |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
