Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
This is an increase over the number of companies cited in the previous month.
Of the 10 citations issued, the most common citation was 'Procedures for corrective and preventive action have not been adequately established'.
All of the companies cited were involved in the Devices sector.
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.
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 |
|---|---|---|---|
| Axiobionics, LLC | Devices | 11/22/2024 | Management review - defined interval, sufficient frequency |
| Axiobionics, LLC | Devices | 11/22/2024 | Lack of or inadequate procedures |
| Axiobionics, LLC | Devices | 11/22/2024 | Investigation of device failures |
| Danmar Products, Inc. | Devices | 11/04/2024 | Training records |
| Danmar Products, Inc. | Devices | 11/04/2024 | Documented evaluation |
| Danmar Products, Inc. | Devices | 11/04/2024 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| Danmar Products, Inc. | Devices | 11/04/2024 | Documentation |
| Danmar Products, Inc. | Devices | 11/04/2024 | Lack of or inadequate receiving acceptance procedures |
| Danmar Products, Inc. | Devices | 11/04/2024 | Lack of or inadequate procedures |
| Danmar Products, Inc. | Devices | 11/04/2024 | Lack of or inadequate complaint procedures |
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