There was one company in a city associated with Lincoln County that received FDA citations as a result of one inspection conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is unchanged from the number of companies cited in the previous year.
The citations in the county include:
- The management representative has not reported on the quality system performance to management with executive responsibility.
- Documents that were obsolete were observed at a location where they are being used.
- Purchasing data that clearly describe or reference specified requirements for purchased or otherwise received product and services have not been approved and established.
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 quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Taiji Medical Supplies, Inc. | Devices | 03/15/2024 | Management representative’s reports |
| Taiji Medical Supplies, Inc. | Devices | 03/15/2024 | Not approved or obsolete document retrieval |
| Taiji Medical Supplies, Inc. | Devices | 03/15/2024 | Approval, inadequate purchasing data |
| Taiji Medical Supplies, Inc. | Devices | 03/15/2024 | Lack of or inadequate process validation |
| Taiji Medical Supplies, Inc. | Devices | 03/15/2024 | Lack of or inadequate final acceptance procedures |
| Taiji Medical Supplies, Inc. | Devices | 03/15/2024 | Lack of or inadequate procedures for labeling |
