Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
This is an increase over the number of companies cited in the previous month.
The citations in the county include:
- A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
- A validated process was not reviewed and evaluated when changes or process deviations occurred.
- Procedures have not been established to control product that does not conform to specified requirements.
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 |
|---|---|---|---|
| Arch Medical Solutions - Elkhart | Devices | 12/18/2024 | Lack of or inadequate process validation |
| Arch Medical Solutions - Elkhart | Devices | 12/18/2024 | Process changes - review, evaluation and revalidation |
| Arch Medical Solutions - Elkhart | Devices | 12/18/2024 | Nonconforming product, Lack of or inadequate procedures |
| Arch Medical Solutions - Elkhart | Devices | 12/18/2024 | Lack of or inadequate complaint procedures |
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