There was one company in a city associated with Whitley 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 an increase over the number of companies cited in the previous year.
The citations in the county include:
- Procedures to control environmental conditions have not been adequately established.
- Procedures to ensure equipment is routinely calibrated have not been adequately established.
- A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
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 quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Red Star Contract Manufacturing, Inc. | Devices | 03/12/2024 | Environmental control Lack of or inadequate procedures |
| Red Star Contract Manufacturing, Inc. | Devices | 03/12/2024 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| Red Star Contract Manufacturing, Inc. | Devices | 03/12/2024 | Lack of or inadequate process validation |
| Red Star Contract Manufacturing, Inc. | Devices | 03/12/2024 | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| Red Star Contract Manufacturing, Inc. | Devices | 03/12/2024 | Lack of or inadequate receiving acceptance procedures |
| Red Star Contract Manufacturing, Inc. | Devices | 03/12/2024 | Lack of or inadequate procedures |
| Red Star Contract Manufacturing, Inc. | Devices | 03/12/2024 | DHR content |
