Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
This is a 14.3% decrease from the number of companies inspected in the previous year, when 21 companies were inspected through 21 inspections.
Most of the companies inspected were involved in the Drugs sector. The second most common type of company inspected in the time period worked in the Food/Cosmetics sector.
There were 10 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (55.6%). Eight should take voluntary action to correct the organization's management operations (44.4%).
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 |
---|---|---|---|
Aspire Pharmaceuticals, Inc. | Drugs | 07/14/2023 | Voluntary Action Indicated (VAI) |
Aspire Pharmaceuticals, Inc. | Food/Cosmetics | 07/14/2023 | No Action Indicated (NAI) |
Catalent Pharma Solutions, LLC | Drugs | 02/01/2023 | No Action Indicated (NAI) |
Catherych, Inc. | Food/Cosmetics | 08/29/2023 | No Action Indicated (NAI) |
Cepham, Inc. | Food/Cosmetics | 02/28/2023 | No Action Indicated (NAI) |
InvaDerm, Inc. | Drugs | 06/28/2023 | Voluntary Action Indicated (VAI) |
Italian Products USA, Inc. | Food/Cosmetics | 06/28/2023 | Voluntary Action Indicated (VAI) |
Janssen Research & Development | Drugs | 03/01/2023 | No Action Indicated (NAI) |
Janssen Research and Development, LLC | Drugs | 06/16/2023 | No Action Indicated (NAI) |
Johnson & Johnson Consumer, Inc. | Food/Cosmetics | 08/25/2023 | No Action Indicated (NAI) |
Light Age, Inc. | Devices | 09/29/2023 | Voluntary Action Indicated (VAI) |
Manara, Dr Louis R | Biologics | 05/23/2023 | Voluntary Action Indicated (VAI) |
Micro Stamping Corporation | Devices | 01/18/2023 | Voluntary Action Indicated (VAI) |
Nexira, Inc. | Food/Cosmetics | 08/30/2023 | No Action Indicated (NAI) |
Novel Laboratories, Inc. | Drugs | 01/13/2023 | Voluntary Action Indicated (VAI) |
Progenics Pharmaceuticals, Inc. | Drugs | 04/21/2023 | No Action Indicated (NAI) |
SOFIE Company | Drugs | 01/20/2023 | Voluntary Action Indicated (VAI) |
Sarah Impex, LLC | Food/Cosmetics | 11/16/2023 | No Action Indicated (NAI) |
UltraRad Corporation | Devices | 08/18/2023 | No Action Indicated (NAI) |