There was one company in a city associated with Florence 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 were ‘The design was not validated under actual or simulated use conditions’ and ‘Design validation did not ensure the device conforms to defined user needs and intended uses’.
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 |
|---|---|---|---|
| DeGen Medical, Inc. | Devices | 09/12/2024 | Design validation – simulated testing |
| DeGen Medical, Inc. | Devices | 09/12/2024 | Design validation – user needs and intended uses |
