There was one company in a city associated with Lake 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:
- No management representative had been appointed to ensure that quality system requirements are met, and to report to management on the performance of the quality system.
- Document control procedures have not been adequately maintained.
- Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements 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 |
|---|---|---|---|
| Technicuff Corporation | Devices | 04/24/2024 | Management representative |
| Technicuff Corporation | Devices | 04/24/2024 | Procedures not adequately established or maintained |
| Technicuff Corporation | Devices | 04/24/2024 | Purchasing controls, Lack of or inadequate procedures |
| Technicuff Corporation | Devices | 04/24/2024 | Nonconforming product, Lack of or inadequate procedures |
| Technicuff Corporation | Devices | 04/24/2024 | Statistical techniques – Lack of or inadequate procedures |
