There was one company in a city associated with Mercer County that received FDA citations as a result of one inspection conducted in the county in 2024, according to 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 organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
- Risk analysis is inadequate.
- 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 and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| FHC, Inc. | Devices | 11/26/2024 | Lack of or inadequate organizational structure |
| FHC, Inc. | Devices | 11/26/2024 | Design Validation – Risk analysis not performed/inadequate |
| FHC, Inc. | Devices | 11/26/2024 | Design validation – user needs and intended uses |
| FHC, Inc. | Devices | 11/26/2024 | Production processes |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
