Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website
Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website
This is unchanged from the number of companies cited in the previous quarter.
The citations in the county include:
- Procedures for management review have not been adequately established.
- Procedures for quality audits have not been established.
- Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
Most of the companies cited were involved in the Biologics 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 |
|---|---|---|---|
| ABC Food Trading, LLC | Food and Cosmetics | 01/12/2024 | Sanitary operations - Plant maintenance |
| AutoMedx, LLC | Devices | 01/18/2024 | Management review - Lack of or inadequate procedures |
| AutoMedx, LLC | Devices | 01/18/2024 | Quality audits - Lack of or inadequate procedures |
| AutoMedx, LLC | Devices | 01/18/2024 | Purchasing controls, Lack of or inadequate procedures |
| AutoMedx, LLC | Devices | 01/18/2024 | Lack of or inadequate complaint procedures |
| Bound Tree Medical, LLC | Devices | 01/31/2024 | Evaluation and Selection, Suppliers, Contractors, etc. |
| Bound Tree Medical, LLC | Devices | 01/31/2024 | Nonconforming product, Lack of or inadequate procedures |
| CSL Plasma, Inc. | Biologics | 02/01/2024 | Establish, maintain and follow manufacturing SOPs |
| Eurofins Donor & Product Testing Dallas, Inc. | Biologics | 03/05/2024 | Manufacturer instructions not followed |
| Eurofins Donor & Product Testing Dallas, Inc. | Biologics | 03/05/2024 | Actions verified, short and long term solutions |
| Eurofins Donor & Product Testing Dallas, Inc. | Biologics | 03/05/2024 | Deviations--evaluation, cause, corrective action |
| Eurofins Donor & Product Testing Dallas, Inc. | Biologics | 03/05/2024 | Design appropriate, suitably located |
| Mozzarella Company | Food and Cosmetics | 01/17/2024 | Sanitary operations - Plant sanitation |
| Mozzarella Company | Food and Cosmetics | 01/17/2024 | Sanitary facilities and controls |
| Mozzarella Company | Food and Cosmetics | 01/17/2024 | Plant operations - Precautions |
| Mozzarella Company | Food and Cosmetics | 01/17/2024 | Manufacturing, processing, packing, holding - Controls |
| Mozzarella Company | Food and Cosmetics | 01/17/2024 | Qualified facility - Attestation |
| Octapharma Plasma, Inc. | Biologics | 03/22/2024 | Provide proper equipment to meet requirements |
| Steri-Tek, LLC | Biologics | 03/26/2024 | Process validation procedures |
| Steri-Tek, LLC | Biologics | 03/26/2024 | Storage temperatures recorded, maintained |
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