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 a 100% increase over the number of companies cited in the previous quarter.
The citations in the county include:
- Requirements that must be met by suppliers have not been adequately established.
- Procedures for acceptance activities have not been adequately established.
- Procedures have not been adequately established to control product that does not conform to specified requirements.
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 |
|---|---|---|---|
| GlaxoSmithKline, LLC | Drugs | 04/19/2024 | Complaint Handling Procedure |
| Suntech Medical, Inc. | Devices | 05/22/2024 | Evaluation of suppliers, contractors, etc., requirements |
| Suntech Medical, Inc. | Devices | 05/22/2024 | Lack of or inadequate procedures - Acceptance activities |
| Suntech Medical, Inc. | Devices | 05/22/2024 | Nonconforming product, Lack of or inadequate procedures |
| Suntech Medical, Inc. | Devices | 05/22/2024 | Lack of or inadequate procedures |
| Suntech Medical, Inc. | Devices | 05/22/2024 | Lack of or inadequate complaint procedures |
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