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 100% increase over the number of companies cited in the previous quarter.
Of the 18 citations issued, the most common citation was 'Procedures have not been adequately established to control product that does not conform to specified requirements'.
Most 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.
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 |
|---|---|---|---|
| Cleveland Airport System | Food and Cosmetics | 02/26/2024 | Prevention of contamination |
| New COS, Inc. | Devices | 03/14/2024 | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| New COS, Inc. | Devices | 03/14/2024 | Nonconforming product, Lack of or inadequate procedures |
| Rhinosystems, Inc. | Devices | 02/08/2024 | Purchasing controls, Lack of or inadequate procedures |
| Rhinosystems, Inc. | Devices | 02/08/2024 | Nonconforming product, Lack of or inadequate procedures |
| Rhinosystems, Inc. | Devices | 02/08/2024 | Lack of or inadequate procedures |
| Rhinosystems, Inc. | Devices | 02/08/2024 | Lack of or inadequate complaint procedures |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Management review - defined interval, sufficient frequency |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Quality Audit/Reaudit - conducted |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Design Validation - Risk analysis not performed/inadequate |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Design history file |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Evaluation and Selection, Suppliers, Contractors, etc. |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Supplier oversight |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Acceptable supplier records, inadequate records |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Nonconforming product control |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Documentation |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Investigation of device failures |
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