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 200% increase over the number of companies cited in the previous month.
The citations in the county include:
- Procedures to validate and approve processes that cannot be fully verified by inspection and tests were not defined.
- Storage temperatures of HCT/Ps were not recorded and maintained.
- Failure of equipment to perform in the manner for which it was designed so as to assure compliance with the official requirements prescribed in 21 CFR 606.
All 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 |
---|---|---|---|
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 |
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 |