Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
This is an increase over the number of companies cited in the previous month.
The citations in the county include:
- Evaluations of out-of-calibration equipment and remedial actions taken were not documented.
- Corrective and preventive action activities and/or results have not been adequately documented.
- Complaint files are not adequately maintained.
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 |
|---|---|---|---|
| Paragon Medical - Dayton | Devices | 09/06/2024 | Remedial action - documentation |
| Paragon Medical - Dayton | Devices | 09/06/2024 | Documentation |
| Paragon Medical - Dayton | Devices | 09/06/2024 | Complaints |
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