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 46.7% decrease from the number of companies inspected in the previous quarter, when 15 companies received 15 inspections.
Most of the companies inspected at the time were involved in the Devices sector. The second most common type of company inspected worked in the Biologics sector.
There were six companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions. Two should take voluntary action to correct their 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.
According to its website, 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.
| Company Name | Area of Business | Inspection Date | Result |
|---|---|---|---|
| Nutek Orthopaedics, Inc. | Devices | 11/19/2024 | Voluntary Action Indicated (VAI) |
| OneBlood, Inc. | Biologics | 10/31/2024 | No Action Indicated (NAI) |
| OneBlood, Inc. | Biologics | 10/29/2024 | No Action Indicated (NAI) |
| Poseidon Medical, Inc. | Devices | 11/12/2024 | No Action Indicated (NAI) |
| Precision Align, LLC | Devices | 11/07/2024 | Voluntary Action Indicated (VAI) |
| Sleep Group Solutions, LLC | Devices | 10/22/2024 | No Action Indicated (NAI) |
| Steven C. Kester, M.D. | Drugs | 12/13/2024 | No Action Indicated (NAI) |
| Vitalgo, Inc. | Devices | 12/13/2024 | No Action Indicated (NAI) |
Alerts Sign-up