Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website
Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website
This is a 100% increase over the number of companies cited in the previous month.
The citations in the county include:
- 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.
- Testing for communicable disease agents was not performed in accordance with the manufacturer's instructions.
- Corrective actions relating to core CGTP requirements have not been verified to ensure effectiveness and compliance with CGTP and did not include both short term corrective actions to address the immediate deficiency and long term corrective actions to prevent recurrence.
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 |
|---|---|---|---|
| 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 |
| LaCore Nutraceuticals, Inc. | Food and Cosmetics | 03/11/2024 | Corrective action plans |
| LaCore Nutraceuticals, Inc. | Food and Cosmetics | 03/11/2024 | Batch record - label |
| LaCore Nutraceuticals, Inc. | Food and Cosmetics | 03/11/2024 | Criteria for establishing specifications |
| Octapharma Plasma, Inc. | Biologics | 03/22/2024 | Provide proper equipment to meet requirements |
Alerts Sign-up