DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
This is a 28.6% increase over the number of companies cited in the previous quarter.
Of the 19 citations issued, the most common citation was 'HCT/P donors were not determined to be eligible based on the results of donor screening and testing'.
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 |
Alfred J. Rodriguez, P. A., M.D. | Biologics | 02/27/2024 | Testing, screening, donor eligibility procedures |
Alfred J. Rodriguez, P. A., M.D. | Biologics | 02/27/2024 | Determination based on screening and testing |
Alfred J. Rodriguez, P. A., M.D. | Biologics | 02/27/2024 | Responsible person to determine, document |
CSL Plasma, Inc. | Biologics | 02/01/2024 | Establish, maintain and follow manufacturing SOPs |
Dallas IVF | Biologics | 03/28/2024 | Determination based on screening and testing |
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 |
Five Star Produce Plus | Food and Cosmetics | 02/28/2024 | Storage and Distribution |
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 |