Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website
Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website
This is unchanged from the number of companies cited in the previous month.
The citations in the county include:
- Procedures for monitoring and control of process parameters for a validated process have not been adequately established.
- Procedures have not been adequately established to control product that does not conform to specified requirements.
- Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system with sufficient frequency.
Both 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.
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 |
|---|---|---|---|
| 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 |
| 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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