Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
This is an increase over the number of companies cited in the previous year.
The citations in the county include:
- Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
- Calibration procedures do not include specific directions and limits for accuracy and precision.
- A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
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.
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 |
|---|---|---|---|
| South Dakota Partners, Inc. | Devices | 09/30/2024 | Purchasing controls, Lack of or inadequate procedures |
| South Dakota Partners, Inc. | Devices | 09/30/2024 | Calibration procedures - content |
| South Dakota Partners, Inc. | Devices | 09/30/2024 | Lack of or inadequate process validation |
| South Dakota Partners, Inc. | Devices | 09/30/2024 | Lack of or inadequate final acceptance procedures |
| South Dakota Partners, Inc. | Devices | 09/30/2024 | Nonconforming product, Lack of or inadequate procedures |
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