Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is a 200% increase over the number of companies cited in the previous quarter.
Of the eight citations issued, the most common citations were 'Procedures for corrective and preventive action have not been adequately established' and 'Complaint files are not adequately maintained'.
All of the companies cited were involved in the Devices sector.
All of the 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 |
|---|---|---|---|
| FloSpine, LLC | Devices | 02/07/2025 | Purchasing controls, Lack of or inadequate procedures |
| FloSpine, LLC | Devices | 02/07/2025 | Lack of or inadequate procedures |
| FloSpine, LLC | Devices | 02/07/2025 | Complaints |
| Peterson Dental Laboratory, Inc. | Devices | 01/08/2025 | Quality audits - auditor independence |
| Peterson Dental Laboratory, Inc. | Devices | 01/08/2025 | Lack of or inadequate procedures |
| Protech Leaded Eyewear | Devices | 03/10/2025 | Quality audits - Lack of or inadequate procedures |
| Protech Leaded Eyewear | Devices | 03/10/2025 | Design control - no procedures |
| Protech Leaded Eyewear | Devices | 03/10/2025 | Complaints |
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