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 20% increase over the number of companies inspected in the previous year, when five companies were inspected through five inspections.
Most of the companies inspected were involved in the Biologics sector. The second most common type of company inspected in the time period worked in the Devices sector.
All of the companies were in line with FDA regulations, and don't need to adjust their managing operations or regulatory/administrative actions.
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 |
---|---|---|---|
CSL Plasma, Inc. | Biologics | 04/28/2023 | No Action Indicated (NAI) |
IntegoGen, LLC | Biologics | 02/03/2023 | No Action Indicated (NAI) |
Marble Medical, Inc. | Devices | 12/12/2023 | No Action Indicated (NAI) |
OneBlood, Inc. | Biologics | 04/25/2023 | No Action Indicated (NAI) |
Southern Biologics, Inc. | Biologics | 03/03/2023 | No Action Indicated (NAI) |
TelaGen, LLC | Biologics | 01/30/2023 | No Action Indicated (NAI) |