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 16.7% decrease from the number of companies inspected in the previous quarter, when six companies received six inspections.
Most of the companies inspected at the time were involved in the Drugs sector. Both the Biologics and Food and Cosmetics sectors sectors tied for second most common type.
There were two companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions. Three 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.
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 |
---|---|---|---|
InvaDerm, Inc. | Drugs | 06/28/2023 | Voluntary Action Indicated (VAI) |
Italian Products USA, Inc. | Food and Cosmetics | 06/28/2023 | Voluntary Action Indicated (VAI) |
Janssen Research and Development, LLC | Drugs | 06/16/2023 | No Action Indicated (NAI) |
Manara, Dr Louis R | Biologics | 05/23/2023 | Voluntary Action Indicated (VAI) |
Progenics Pharmaceuticals, Inc. | Drugs | 04/21/2023 | No Action Indicated (NAI) |