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 inspected in the previous month, when four companies received four inspections.
Most of the companies inspected at the time were involved in the Biologics sector. The second most common type of company inspected period worked in the Food and Cosmetics sector.
There were three companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions. Four should take voluntary action to correct the organization's management 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 | Result |
---|---|---|---|
Air Culinaire | Food and Cosmetics | 03/25/2024 | No Action Indicated (NAI) |
Baylor Scott & White All Saints Medical Center | Biologics | 03/22/2024 | No Action Indicated (NAI) |
Dallas IVF | Biologics | 03/28/2024 | Voluntary Action Indicated (VAI) |
Eurofins Donor & Product Testing Dallas, Inc. | Biologics | 03/05/2024 | Voluntary Action Indicated (VAI) |
Octapharma Plasma, Inc. | Biologics | 03/22/2024 | Voluntary Action Indicated (VAI) |
Octapharma Plasma, Inc. | Biologics | 03/01/2024 | No Action Indicated (NAI) |
Steri-Tek, LLC | Biologics | 03/26/2024 | Voluntary Action Indicated (VAI) |