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 over the first quarter of 2025, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 50% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- The written MDR procedure does not include an internal system which provides for timely transmission of complete medical device reports to FDA.
- Procedures for design review have not been established.
- Procedures for design validation have not been adequately 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 |
|---|---|---|---|
| Lingraphicare America, Inc. | Devices | 02/03/2025 | Lack of System for Timely Submission of Reports |
| Lingraphicare America, Inc. | Devices | 02/03/2025 | Design review – Lack of or inadequate procedures |
| Lingraphicare America, Inc. | Devices | 02/03/2025 | Design validation- Lack of or inadequate procedures |
| Lingraphicare America, Inc. | Devices | 02/03/2025 | Document review, approval documentation |
| Lingraphicare America, Inc. | Devices | 02/03/2025 | Lack of or inadequate procedures |
| Lingraphicare America, Inc. | Devices | 02/03/2025 | Lack of or inadequate complaint procedures |
