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 quarter.
The citations in the county include:
- Procedures for design change have not been adequately established.
- Procedures for acceptance activities have not been adequately established.
- Procedures for corrective and preventive action 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.
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 |
|---|---|---|---|
| Newman Medical | Devices | 09/25/2024 | Design changes - Lack of or Inadequate Procedures |
| Newman Medical | Devices | 09/25/2024 | Lack of or inadequate procedures - Acceptance activities |
| Newman Medical | Devices | 09/25/2024 | Lack of or inadequate procedures |
| Newman Medical | Devices | 09/25/2024 | DMR - not or inadequately maintained |
| Newman Medical | Devices | 09/25/2024 | DHR - not or inadequately maintained |
| Newman Medical | Devices | 09/25/2024 | Servicing - Lack of or inadequate procedures |
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