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West OC Times

Thursday, November 7, 2024

FDA conducted inspections of 19 companies in cities located in Orange County in Q1

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Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

There were 19 companies in cities associated with Orange County, California, that received 19 FDA inspections in the first quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 29.6% decrease from the number of companies inspected in the previous quarter, when 27 companies received 28 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 15 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (78.9%). Four should take voluntary action to correct their management operations (21.1%).

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 Orange County and Their Inspection Results
Company NameArea of BusinessInspection DateResult
American National Red Cross, TheBiologics02/09/2024No Action Indicated (NAI)
American National Red Cross, TheBiologics02/28/2024No Action Indicated (NAI)
BioDuro, LLCDrugs02/23/2024Voluntary Action Indicated (VAI)
Biogennix, LLCDevices02/08/2024Voluntary Action Indicated (VAI)
CDHT, Inc.Food and Cosmetics01/16/2024No Action Indicated (NAI)
Calafia Growers, Inc.Food and Cosmetics02/06/2024No Action Indicated (NAI)
Children's Hospital of Orange CountyBiologics01/16/2024Voluntary Action Indicated (VAI)
CorneaGenBiologics03/25/2024No Action Indicated (NAI)
Ezaki Glico USA CorporationFood and Cosmetics03/28/2024No Action Indicated (NAI)
Flavorchem CorporationFood and Cosmetics02/07/2024Voluntary Action Indicated (VAI)
G. T Japan, Inc.Food and Cosmetics02/13/2024No Action Indicated (NAI)
Gem Pack Berries, LLCFood and Cosmetics01/25/2024No Action Indicated (NAI)
Ikeda Tea World, Inc.Food and Cosmetics01/19/2024No Action Indicated (NAI)
Indian Wells Medical, Inc.Devices01/10/2024No Action Indicated (NAI)
Nordson Medical, LLCDevices03/14/2024No Action Indicated (NAI)
Seapoint FarmsFood and Cosmetics01/16/2024No Action Indicated (NAI)
Stremicks Heritage Foods, LLCFood and Cosmetics03/20/2024No Action Indicated (NAI)
Trelleborg Sealing Solutions US, Inc.Devices02/29/2024No Action Indicated (NAI)
Viking Rubber Products, Inc.Devices02/15/2024No Action Indicated (NAI)

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