James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is a 75% increase over the number of companies cited in the previous quarter.
Of the 27 citations issued, the most common citation was 'You did not maintain your plant in a clean and sanitary condition and in adequate repair'.
Most of the companies cited were involved in either Food and Cosmetics or Biologics sectors.
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 |
| Full Quiver Farms | Food and Cosmetics | 03/13/2024 | Grounds |
| Full Quiver Farms | Food and Cosmetics | 03/13/2024 | Sanitary operations - Plant maintenance |
| Full Quiver Farms | Food and Cosmetics | 03/13/2024 | Sanitary operations - Plant sanitation |
| Full Quiver Farms | Food and Cosmetics | 03/13/2024 | Toxic chemicals - Identified, held, stored |
| Full Quiver Farms | Food and Cosmetics | 03/13/2024 | Sanitation of food-contact surfaces - Frequency |
| Full Quiver Farms | Food and Cosmetics | 03/13/2024 | Equipment and utensils - Design and maintenance |
| 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 |
| Natural Technology, LLC | Drugs | 03/01/2024 | Procedures not in writing, fully followed |
| Natural Technology, LLC | Drugs | 03/01/2024 | Plumbing System Defects |
| Natural Technology, LLC | Drugs | 03/01/2024 | Buildings not maintained in good state of repair |
| Natural Technology, LLC | Drugs | 03/01/2024 | Equipment Design, Size and Location |
| Natural Technology, LLC | Drugs | 03/01/2024 | Cleaning / Sanitizing / Maintenance |
| Natural Technology, LLC | Drugs | 03/01/2024 | Component identity verification |
| Natural Technology, LLC | Drugs | 03/01/2024 | Calibration - at intervals, written program, remedial action |
| Natural Technology, LLC | Drugs | 03/01/2024 | Microbiological testing |
| Natural Technology, LLC | Drugs | 03/01/2024 | Investigations of discrepancies, failures |
| Octapharma Plasma, Inc. | Biologics | 03/22/2024 | Provide proper equipment to meet requirements |
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