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 80% decrease from the number of companies cited in the previous month.
The citations in the county were 'Acceptance activities were not maintained as part of the device history record and adequately documented' and '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 |
|---|---|---|---|
| Chitogen, Inc. | Devices | 03/19/2024 | Documentation |
| Chitogen, Inc. | Devices | 03/19/2024 | Lack of or inadequate procedures |
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