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 13% decrease from the number of companies inspected in the previous year, when 23 companies were inspected through 23 inspections.
Most of the companies inspected were involved in the Food/Cosmetics sector. The second most common type of company inspected in the time period worked in the Drugs sector.
There were 13 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (65%). Seven should take voluntary action to correct the organization's management operations (35%).
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 |
---|---|---|---|
8th Avenue Food & Provisions, Inc. | Food/Cosmetics | 04/27/2023 | No Action Indicated (NAI) |
Atlas Ocular, Inc. | Biologics | 06/09/2023 | No Action Indicated (NAI) |
CS Group | Food/Cosmetics | 11/20/2023 | No Action Indicated (NAI) |
Castle IRB | Biologics | 09/15/2023 | No Action Indicated (NAI) |
Castle IRB | Devices | 09/15/2023 | No Action Indicated (NAI) |
Castle IRB | Drugs | 09/15/2023 | No Action Indicated (NAI) |
Curium US, LLC | Drugs | 08/18/2023 | Voluntary Action Indicated (VAI) |
Genus Medical Technologies | Food/Cosmetics | 06/28/2023 | No Action Indicated (NAI) |
Helget Gas Products, Inc. | Drugs | 05/25/2023 | Voluntary Action Indicated (VAI) |
International Food Products - R&D Lab | Food/Cosmetics | 03/16/2023 | No Action Indicated (NAI) |
Kakao, Inc. | Food/Cosmetics | 02/15/2023 | No Action Indicated (NAI) |
Legacy Pharmaceutical Packaging, LLC | Food/Cosmetics | 11/21/2023 | No Action Indicated (NAI) |
M & L Trading, Inc. | Food/Cosmetics | 04/06/2023 | Voluntary Action Indicated (VAI) |
Medix Biochemica USA, Inc. | Biologics | 05/03/2023 | No Action Indicated (NAI) |
National Dentex, LLC | Devices | 03/17/2023 | Voluntary Action Indicated (VAI) |
Phyto Vita | Food/Cosmetics | 04/26/2023 | No Action Indicated (NAI) |
Pro Pharma, LLC | Food/Cosmetics | 05/09/2023 | No Action Indicated (NAI) |
SpecGx, LLC | Drugs | 09/18/2023 | Voluntary Action Indicated (VAI) |
St. Luke's Hospital Blood Bank | Biologics | 11/16/2023 | No Action Indicated (NAI) |
TAGG Logistics, LLC | Food/Cosmetics | 04/26/2023 | No Action Indicated (NAI) |
Virbac Corporation | Drugs | 07/28/2023 | Voluntary Action Indicated (VAI) |
Virbac Corporation | Veterinary | 07/28/2023 | Voluntary Action Indicated (VAI) |
ZeaVision Holdings, Inc. | Food/Cosmetics | 05/18/2023 | Voluntary Action Indicated (VAI) |