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 34.6% decrease from the number of companies inspected in the previous quarter, when 26 companies received 26 inspections.
Most of the companies inspected at the time were involved in the Devices and Food and Cosmetics sectors. The second most common type of company inspected worked in the Drugs sector.
There were 13 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (76.5%). Four should take voluntary action to correct their management operations (23.5%).
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 |
|---|---|---|---|
| Aaron Gourmet Food Imports, Inc. | Food and Cosmetics | 06/01/2023 | Voluntary Action Indicated (VAI) |
| Alexander E. Drilon, M.D. | Drugs | 06/16/2023 | No Action Indicated (NAI) |
| Alexander M. Lesokhin, M.D. | Drugs | 04/12/2023 | Voluntary Action Indicated (VAI) |
| Creodent Prosthetics, Ltd. | Devices | 06/14/2023 | Voluntary Action Indicated (VAI) |
| Cyberlogic, Inc. | Devices | 05/24/2023 | No Action Indicated (NAI) |
| Gina Group, LLC | Food and Cosmetics | 05/25/2023 | No Action Indicated (NAI) |
| Gourmet Attitude, Inc. | Food and Cosmetics | 06/30/2023 | No Action Indicated (NAI) |
| Jim W. Cheung, M.D. | Devices | 06/30/2023 | No Action Indicated (NAI) |
| Manhattan Fertility Services, LLC | Biologics | 04/06/2023 | Voluntary Action Indicated (VAI) |
| New York University Fertility Center | Biologics | 06/29/2023 | No Action Indicated (NAI) |
| Ogilvie Brand, Inc. | Food and Cosmetics | 05/10/2023 | No Action Indicated (NAI) |
| Splendid World, Corp. | Food and Cosmetics | 05/11/2023 | No Action Indicated (NAI) |
| Steven Markowitz, M.D. | Devices | 04/26/2023 | No Action Indicated (NAI) |
| VA NY Harbor Healthcare System IRB | Devices | 05/05/2023 | No Action Indicated (NAI) |
| VA NY Harbor Healthcare System IRB | Drugs | 05/05/2023 | No Action Indicated (NAI) |
| Weill Cornell Med College IRB | Biologics | 06/07/2023 | No Action Indicated (NAI) |
| Weill Cornell Med College IRB | Devices | 06/07/2023 | No Action Indicated (NAI) |
| Weill Cornell Med College IRB | Drugs | 06/07/2023 | No Action Indicated (NAI) |
| Wing-On Trading Company, Inc. | Food and Cosmetics | 06/02/2023 | No Action Indicated (NAI) |
| Zbigniew P. Lorenc, M.D. | Drugs | 06/21/2023 | No Action Indicated (NAI) |
Alerts Sign-up