James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is an increase over the number of companies cited in the previous month.
The citations in the county include:
- A device master record has not been adequately maintained.
- A device history record has not been adequately maintained.
- Requirements that must be met by suppliers have not been adequately established.
Both companies cited should take voluntary actions to correct their 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 |
|---|---|---|---|
| Cogmedix, Inc. | Devices | 04/11/2024 | Evaluation of suppliers, contractors, etc., requirements |
| Cogmedix, Inc. | Devices | 04/11/2024 | Product rework procedures, Lack of or inadequate procedures |
| Cogmedix, Inc. | Devices | 04/11/2024 | Lack of or inadequate procedures |
| Cogmedix, Inc. | Devices | 04/11/2024 | Failure to report |
| Image Diagnostics, Inc. | Devices | 04/18/2024 | DMR - not or inadequately maintained |
| Image Diagnostics, Inc. | Devices | 04/18/2024 | DHR - not or inadequately maintained |
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