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 53.8% decrease from the number of companies inspected in the previous quarter, when 13 companies received 13 inspections.
The companies inspected were involved in either the Biologics, Devices, or Drugs sectors.
There were five companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions. One should take voluntary action to correct its 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 |
|---|---|---|---|
| American Red Cross Blood Services | Biologics | 08/13/2024 | No Action Indicated (NAI) |
| Chiesi USA, Inc. | Drugs | 08/01/2024 | No Action Indicated (NAI) |
| Digisonics, Inc. | Devices | 08/12/2024 | No Action Indicated (NAI) |
| Indivior Manufacturing, LLC | Drugs | 07/26/2024 | Voluntary Action Indicated (VAI) |
| James P. Zidar, M.D. | Devices | 08/07/2024 | No Action Indicated (NAI) |
| Rex Hospital, Inc. | Biologics | 09/09/2024 | No Action Indicated (NAI) |
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