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Tuesday, November 5, 2024

FDA conducted inspections of 18 companies in cities located in Richmond County in Q2 2023

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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

There were 18 companies in cities associated with Richmond County, New York, that received 18 FDA inspections in the second quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 40% decrease from the number of companies inspected in the previous quarter, when 30 companies received 30 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 Devices sector.

There were 13 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (72.2%). Five should take voluntary action to correct their management operations (27.8%).

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.

Companies Located in Cities Within Richmond County and Their Inspection Results
Company NameArea of BusinessInspection DateResult
Aaron Gourmet Food Imports, Inc.Food and Cosmetics06/01/2023Voluntary Action Indicated (VAI)
Alexander E. Drilon, M.D.Drugs06/16/2023No Action Indicated (NAI)
Alexander M. Lesokhin, M.D.Drugs04/12/2023Voluntary Action Indicated (VAI)
Creodent Prosthetics, Ltd.Devices06/14/2023Voluntary Action Indicated (VAI)
Cyberlogic, Inc.Devices05/24/2023No Action Indicated (NAI)
Gina Group, LLCFood and Cosmetics05/25/2023No Action Indicated (NAI)
Gourmet Attitude, Inc.Food and Cosmetics06/30/2023No Action Indicated (NAI)
Jim W. Cheung, M.D.Devices06/30/2023No Action Indicated (NAI)
Manhattan Fertility Services, LLCBiologics04/06/2023Voluntary Action Indicated (VAI)
New York University Fertility CenterBiologics06/29/2023No Action Indicated (NAI)
Ogilvie Brand, Inc.Food and Cosmetics05/10/2023No Action Indicated (NAI)
Splendid World, Corp.Food and Cosmetics05/11/2023No Action Indicated (NAI)
Steven Markowitz, M.D.Devices04/26/2023No Action Indicated (NAI)
VA NY Harbor Healthcare System IRBDevices05/05/2023No Action Indicated (NAI)
VA NY Harbor Healthcare System IRBDrugs05/05/2023No Action Indicated (NAI)
Weill Cornell Med College IRBBiologics06/07/2023No Action Indicated (NAI)
Weill Cornell Med College IRBDevices06/07/2023No Action Indicated (NAI)
Weill Cornell Med College IRBDrugs06/07/2023No Action Indicated (NAI)
Wing-On Trading Company, Inc.Food and Cosmetics06/02/2023No Action Indicated (NAI)
Xin Ao International Group / Xin Ao Properties Usa Lius Group, Corp.Food and Cosmetics05/22/2023Voluntary Action Indicated (VAI)
Zbigniew P. Lorenc, M.D.Drugs06/21/2023No Action Indicated (NAI)

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