There was one company in a city associated with Santa Clara County that received FDA citations as a result of one inspection conducted in the county in July, 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 month.
The citations in the county include:
- There is no record maintained of a correction or removal action that was not required to be reported to FDA.
- Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system with sufficient frequency.
- Personnel training is not documented.
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.
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, according to its website.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Imedrix, Inc. | Devices | 07/24/2024 | Records not kept |
| Imedrix, Inc. | Devices | 07/24/2024 | Management review – defined interval, sufficient frequency |
| Imedrix, Inc. | Devices | 07/24/2024 | Training records |
| Imedrix, Inc. | Devices | 07/24/2024 | Design Validation – Risk analysis not performed/inadequate |
| Imedrix, Inc. | Devices | 07/24/2024 | Procedures not adequately established or maintained |
| Imedrix, Inc. | Devices | 07/24/2024 | Acceptable supplier records, inadequate records |
| Imedrix, Inc. | Devices | 07/24/2024 | Documentation |
| Imedrix, Inc. | Devices | 07/24/2024 | Complaints |
