Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
This is unchanged from the number of companies cited in the previous quarter.
The citations in the county include:
- You did not maintain your plant in a clean and sanitary condition and in adequate repair.
- Written standard operating procedures including all steps to be followed in the storage of blood and blood components for further manufacturing purposes were not always followed.
- You did not clean and sanitize your utensils or equipment in a manner that protects against allergen cross-contact and contamination.
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 |
| 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 |
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