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 an 11.1% increase over the number of companies inspected in the previous quarter, when 18 companies received 18 inspections.
Most of the companies inspected at the time were involved in the Food and Cosmetics sector. The second most common type of company inspected worked in the Biologics sector.
There were 13 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (65%). Seven should take voluntary action to correct their 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 |
---|---|---|---|
Adja Khady Food Distribution, Inc. | Food and Cosmetics | 08/22/2023 | Voluntary Action Indicated (VAI) |
Applevalley Organics, Corporation, Inc. | Veterinary | 08/16/2023 | Voluntary Action Indicated (VAI) |
Argo Import, Inc. | Food and Cosmetics | 08/31/2023 | No Action Indicated (NAI) |
Danielle Iacono, OD | Drugs | 07/31/2023 | No Action Indicated (NAI) |
G21 USA, Inc. | Devices | 07/25/2023 | Voluntary Action Indicated (VAI) |
GeneXtend, LLC | Biologics | 09/13/2023 | No Action Indicated (NAI) |
Genuine Coconut, Inc. | Food and Cosmetics | 09/12/2023 | No Action Indicated (NAI) |
ILG International Trading | Food and Cosmetics | 09/22/2023 | No Action Indicated (NAI) |
J&H Imports Services Corporation | Food and Cosmetics | 08/02/2023 | Voluntary Action Indicated (VAI) |
Kofinas Fertility Group | Biologics | 07/25/2023 | Voluntary Action Indicated (VAI) |
Lindsey Roeker, M.D. | Drugs | 09/12/2023 | No Action Indicated (NAI) |
Milos, Inc. | Food and Cosmetics | 08/11/2023 | No Action Indicated (NAI) |
New York Blood Center Enterprises | Biologics | 07/06/2023 | Voluntary Action Indicated (VAI) |
New York Presbyterian Hospital Services | Biologics | 08/21/2023 | No Action Indicated (NAI) |
New York Presbyterian Hospital Weill Cornell Medical College | Biologics | 07/25/2023 | No Action Indicated (NAI) |
Palace Kosher, Corp. | Food and Cosmetics | 09/27/2023 | No Action Indicated (NAI) |
Rip Van, Inc. | Food and Cosmetics | 08/22/2023 | No Action Indicated (NAI) |
Sojitz Corporation of America | Veterinary | 08/11/2023 | Voluntary Action Indicated (VAI) |
Stemline Therapeutics, Inc. | Drugs | 08/31/2023 | No Action Indicated (NAI) |
The Rockefeller University Institutional Review Board | Biologics | 08/14/2023 | No Action Indicated (NAI) |
The Rockefeller University Institutional Review Board | Devices | 08/14/2023 | No Action Indicated (NAI) |
The Rockefeller University Institutional Review Board | Drugs | 08/14/2023 | No Action Indicated (NAI) |