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 were 'The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820' and 'Quality system procedures and instructions have not been 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 |
|---|---|---|---|
| Nasorcap Medical, Inc. | Devices | 01/22/2024 | Lack of or inadequate organizational structure |
| Nasorcap Medical, Inc. | Devices | 01/22/2024 | Quality System Procedures |
Alerts Sign-up