There were two companies in cities associated with Luzerne 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 an increase over the number of companies cited in the previous year.
The citations in the county include:
- Incoming HCT/Ps were not inspected for damage and contamination.
- Appropriate shipping conditions were not established and defined for each type of HCT/P.
- Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
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 |
|---|---|---|---|
| Benco Dental Supply Company | Biologics | 07/26/2024 | Evaluation–microorganisms, damage |
| Benco Dental Supply Company | Biologics | 07/26/2024 | Shipping conditions appropriate |
| Henkel US Operations Corporation | Drugs | 01/18/2024 | Complaint Handling Procedure |
