There were three companies in cities associated with Somerset County that received FDA citations as a result of three inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 50% decrease from the number of companies cited in the previous year.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not fully followed.
- You did not have a written hazard analysis.
- You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier’s performance and the risk posed by a food.
All of the companies cited were involved in either Drugs, Food and Cosmetics, or Devices sectors.
All of the 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 |
|---|---|---|---|
| A3K Imports, LLC | Food and Cosmetics | 07/03/2024 | Hazard analysis written |
| A3K Imports, LLC | Food and Cosmetics | 07/03/2024 | Evaluation – performance, risk |
| A3K Imports, LLC | Food and Cosmetics | 07/03/2024 | Supplier approval – document |
| A3K Imports, LLC | Food and Cosmetics | 07/03/2024 | Approved supplier procedures – importer established |
| A3K Imports, LLC | Food and Cosmetics | 07/03/2024 | Investigate |
| L’Oreal USA Products, Inc. | Drugs | 02/15/2024 | Procedures not in writing, fully followed |
| Trutek, Corp. | Devices | 01/18/2024 | Label to bear a unique device identifier |
| Trutek, Corp. | Devices | 01/18/2024 | Lack of Written MDR Procedures |
| Trutek, Corp. | Devices | 01/18/2024 | Quality System Procedures |
| Trutek, Corp. | Devices | 01/18/2024 | Design control – no procedures |
| Trutek, Corp. | Devices | 01/18/2024 | Lack of procedures, or not maintained |
| Trutek, Corp. | Devices | 01/18/2024 | Purchasing controls, Lack of or inadequate procedures |
| Trutek, Corp. | Devices | 01/18/2024 | Environmental control Lack of or inadequate procedures |
| Trutek, Corp. | Devices | 01/18/2024 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| Trutek, Corp. | Devices | 01/18/2024 | Lack of or inadequate procedures – Acceptance activities |
| Trutek, Corp. | Devices | 01/18/2024 | Nonconforming product, Lack of or inadequate procedures |
| Trutek, Corp. | Devices | 01/18/2024 | Lack of or inadequate procedures |
| Trutek, Corp. | Devices | 01/18/2024 | Lack of or inadequate complaint procedures |
