There was one company in a city associated with Carroll County that received FDA citations as a result of one inspection 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 labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830.
- Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established.
- Procedures to ensure equipment is routinely calibrated, inspected, checked and maintained have not been established.
The company cited was involved in the Devices sector.
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 and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| RAC Medical Solutions | Devices | 08/07/2025 | Label to bear a unique device identifier |
| RAC Medical Solutions | Devices | 08/07/2025 | Purchasing controls, Lack of or inadequate procedures |
| RAC Medical Solutions | Devices | 08/07/2025 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| RAC Medical Solutions | Devices | 08/07/2025 | Lack of or inadequate procedures – Acceptance activities |
| RAC Medical Solutions | Devices | 08/07/2025 | Nonconforming product, Lack of or inadequate procedures |
| RAC Medical Solutions | Devices | 08/07/2025 | Documentation |
| RAC Medical Solutions | Devices | 08/07/2025 | Lack of or inadequate procedures for labeling |
| RAC Medical Solutions | Devices | 08/07/2025 | DHR – not or inadequately maintained |
| RAC Medical Solutions | Devices | 08/07/2025 | Lack of or inadequate DHR procedures |
| RAC Medical Solutions | Devices | 08/07/2025 | Devices subject to device identification GUDID data submission requirements. |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
