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Wednesday, November 6, 2024

How many companies in cities in Orange County received FDA inspections in 2023?

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Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

There were 156 companies in cities associated with Orange County, California, that received 160 FDA inspections in 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 20% increase over the number of companies inspected in the previous year, when 130 companies were inspected through 132 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 Devices sector.

There were 82 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (52.6%). 67 should take voluntary action to correct the organization's management operations (42.9%). Additionally, seven companies had to take regulatory and/or administrative actions (4.5%).

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.

Companies Located in Cities Within Orange County and Their Inspection Results
Company NameArea of BusinessInspection DateResult
ABS Wholesale, Inc.Tobacco03/31/2023Voluntary Action Indicated (VAI)
Acacio Fertility CenterBiologics11/28/2023No Action Indicated (NAI)
Albertsons, LLCFood/Cosmetics05/18/2023No Action Indicated (NAI)
Allergan Sales, LLCDrugs07/28/2023No Action Indicated (NAI)
Alumni PartnersFood/Cosmetics03/08/2023Voluntary Action Indicated (VAI)
Amy USA Group, Inc.Tobacco04/24/2023No Action Indicated (NAI)
Anand K. Ganesan, Ph. D., M.D.Biologics04/26/2023No Action Indicated (NAI)
Ari's Wholesale, LLCFood/Cosmetics08/09/2023Voluntary Action Indicated (VAI)
Asahi Intecc Usa, Inc.Devices06/01/2023Voluntary Action Indicated (VAI)
Austina B. Cho, M.D.Drugs03/31/2023No Action Indicated (NAI)
B. Braun Medical, Inc.Drugs12/15/2023Voluntary Action Indicated (VAI)
B. Braun Medical, Inc.Devices10/13/2023No Action Indicated (NAI)
Balance Factor, Inc.Food/Cosmetics06/06/2023Voluntary Action Indicated (VAI)
Balt USA, LLCDevices07/21/2023Voluntary Action Indicated (VAI)
Barohup, Inc.Food/Cosmetics08/21/2023Voluntary Action Indicated (VAI)
Beverage Visions, LLCFood/Cosmetics09/06/2023No Action Indicated (NAI)
Bhavraj Khalsa, M.D.Devices10/25/2023No Action Indicated (NAI)
BlueTriton BrandsFood/Cosmetics01/05/2023No Action Indicated (NAI)
Boba Boyz, LLCFood/Cosmetics04/11/2023Voluntary Action Indicated (VAI)
Bread Artisan Bakery, Inc.Food/Cosmetics08/18/2023Voluntary Action Indicated (VAI)
CJ Foods Manufacturing CorporationFood/Cosmetics02/23/2023Voluntary Action Indicated (VAI)
CJ Foods USA, A Division of CJ America, Inc.Food/Cosmetics02/02/2023No Action Indicated (NAI)
CVS Health, Inc.Food/Cosmetics09/20/2023No Action Indicated (NAI)
CVS Pharmacy, Inc.Food/Cosmetics10/16/2023No Action Indicated (NAI)
Calmo Manufacturing, Inc.Drugs08/04/2023No Action Indicated (NAI)
Canary Trading Company, Inc.Food/Cosmetics03/14/2023No Action Indicated (NAI)
Chileman Imports, LLCFood/Cosmetics02/23/2023No Action Indicated (NAI)
Citro Fresh, LLCFood/Cosmetics08/28/2023Voluntary Action Indicated (VAI)
Clinical Resolution Laboratory, Inc.Drugs09/29/2023Official Action Indicated (OAI)
Cloud 9 Distributors, LLCTobacco09/21/2023Voluntary Action Indicated (VAI)
Clyra Medical Technologies, Inc.Devices05/16/2023No Action Indicated (NAI)
Cobasa, Inc.Food/Cosmetics01/26/2023No Action Indicated (NAI)
Cognita Labs, LLCDevices12/13/2023Voluntary Action Indicated (VAI)
Cookie Jar Collection, Inc.Food/Cosmetics10/06/2023Voluntary Action Indicated (VAI)
DS Services of America, Inc.Food/Cosmetics06/01/2023Voluntary Action Indicated (VAI)
Dang Vu, Inc.Food/Cosmetics07/06/2023Voluntary Action Indicated (VAI)
Daniel D. Truong, M.D.Drugs06/09/2023No Action Indicated (NAI)
David L. Wirta, M.D.Drugs04/06/2023No Action Indicated (NAI)
David P. Walling, Ph. D.Drugs01/13/2023Voluntary Action Indicated (VAI)
Dendreon Pharmaceuticals, LLCBiologics08/10/2023Voluntary Action Indicated (VAI)
Dkb Household UsaFood/Cosmetics04/11/2023Voluntary Action Indicated (VAI)
Ecom Medical, Inc.Devices01/18/2023No Action Indicated (NAI)
Ehsan Sadri, M.D.Drugs09/15/2023No Action Indicated (NAI)
Electronic Waveform Lab, Inc.Devices01/11/2023No Action Indicated (NAI)
Elite BioFusion, LLCBiologics09/29/2023Voluntary Action Indicated (VAI)
Elly R. Lee, M.D.Drugs08/16/2023No Action Indicated (NAI)
Envita Fertility CenterBiologics10/06/2023Voluntary Action Indicated (VAI)
Fertility Center of Orange County, A Medical Group, Inc.Biologics08/29/2023Voluntary Action Indicated (VAI)
First Biotech, Inc.Food/Cosmetics09/14/2023Voluntary Action Indicated (VAI)
Flowers Baking Company of Henderson WarehouseFood/Cosmetics12/12/2023No Action Indicated (NAI)
Frieda's, Inc.Food/Cosmetics03/14/2023No Action Indicated (NAI)
Gaylords meat CompanyFood/Cosmetics03/15/2023No Action Indicated (NAI)
Genesis Biologics, Inc.Biologics07/21/2023Voluntary Action Indicated (VAI)
Giulianos' Specialty Foods, Inc.Food/Cosmetics09/05/2023No Action Indicated (NAI)
Golden State Foods Crop.Food/Cosmetics10/23/2023No Action Indicated (NAI)
Greenfruit Avocados, LLCFood/Cosmetics06/06/2023Voluntary Action Indicated (VAI)
HCN Industries, Inc.Food/Cosmetics08/16/2023Voluntary Action Indicated (VAI)
Have'a Natural Foods, Inc.Food/Cosmetics01/13/2023Voluntary Action Indicated (VAI)
Hepatiq, Inc.Devices07/12/2023No Action Indicated (NAI)
Houdini, Inc.Food/Cosmetics08/24/2023No Action Indicated (NAI)
Huntington Reproductive Center Medical GroupBiologics03/28/2023Voluntary Action Indicated (VAI)
Inmar Supply Chain Solutions, LLCFood/Cosmetics03/14/2023No Action Indicated (NAI)
Inmar Supply Chain Solutions, LLCVeterinary03/14/2023No Action Indicated (NAI)
Innovative Beverage CONCEPTSFood/Cosmetics01/11/2023No Action Indicated (NAI)
Interfresh, Inc.Food/Cosmetics10/23/2023Voluntary Action Indicated (VAI)
Ioniki Foods, Inc.Food/Cosmetics03/29/2023No Action Indicated (NAI)
Island Snacks, Inc.Food/Cosmetics11/29/2023No Action Indicated (NAI)
Joanna Van, M.D.Drugs08/11/2023No Action Indicated (NAI)
Just Food For Dogs - IrvineVeterinary07/26/2023No Action Indicated (NAI)
KB Transpacific Trading, LLCFood/Cosmetics06/06/2023Voluntary Action Indicated (VAI)
Kat & ELL, Corp.Food/Cosmetics02/21/2023Voluntary Action Indicated (VAI)
Kendall Frozen FruitsFood/Cosmetics02/22/2023No Action Indicated (NAI)
Khalil Mamoon Usa, Inc.Tobacco04/24/2023No Action Indicated (NAI)
L & R Fine Food, Inc.Food/Cosmetics06/28/2023Voluntary Action Indicated (VAI)
LQNN, Inc.Food/Cosmetics05/31/2023No Action Indicated (NAI)
La Cabana Food DistributorFood/Cosmetics10/12/2023Voluntary Action Indicated (VAI)
Lightmed USA, Inc.Devices08/09/2023No Action Indicated (NAI)
Links Medical Products, Inc.Devices10/18/2023Voluntary Action Indicated (VAI)
MPS Pharma & Medical, Inc.Devices07/28/2023No Action Indicated (NAI)
MSJ Foods, Inc.Food/Cosmetics11/15/2023Voluntary Action Indicated (VAI)
Maiko CorporationFood/Cosmetics04/15/2023No Action Indicated (NAI)
Majestic International GroupFood/Cosmetics08/01/2023No Action Indicated (NAI)
Marc Pro, Inc.Devices01/11/2023No Action Indicated (NAI)
Marketshield, Inc.Food/Cosmetics02/27/2023No Action Indicated (NAI)
Maruchan, Inc.Food/Cosmetics08/16/2023No Action Indicated (NAI)
Marukome USA, Inc.Food/Cosmetics08/08/2023Voluntary Action Indicated (VAI)
Medsource PharmaceuticalsDrugs12/11/2023Voluntary Action Indicated (VAI)
Meta Dynamic IncorporatedDevices07/17/2023Voluntary Action Indicated (VAI)
Mettler Electronics CorporationDevices09/14/2023Voluntary Action Indicated (VAI)
Microvention, Inc.Devices05/04/2023Voluntary Action Indicated (VAI)
Minh Phung, Inc.Food/Cosmetics05/04/2023Voluntary Action Indicated (VAI)
Minhs Meat Company, Inc.Food/Cosmetics01/05/2023Voluntary Action Indicated (VAI)
Misako Nagasaka, M.D.Drugs07/14/2023No Action Indicated (NAI)
Nataliya Mar, M.D.Drugs02/03/2023No Action Indicated (NAI)
Natural Food Ingredients, Inc.Food/Cosmetics06/01/2023No Action Indicated (NAI)
Neurotris, Inc.Devices04/25/2023Official Action Indicated (OAI)
New Health Products, Inc.Food/Cosmetics02/08/2023Voluntary Action Indicated (VAI)
Newport Beach IVF, LLCBiologics12/13/2023No Action Indicated (NAI)
Nihon Kohden Digital Health Solutions, Inc.Devices06/13/2023No Action Indicated (NAI)
Nina Mia, Inc.Food/Cosmetics10/16/2023Voluntary Action Indicated (VAI)
Nitto Avecia Pharma Services, Inc.Veterinary09/22/2023Voluntary Action Indicated (VAI)
Nor-Cal Beverage Company, Inc.Food/Cosmetics07/27/2023No Action Indicated (NAI)
Nor-Cal Beverage Company, Inc.Food/Cosmetics03/22/2023No Action Indicated (NAI)
Nutralliance, Inc.Food/Cosmetics01/30/2023No Action Indicated (NAI)
Nutrawise Health & Beauty, LLCFood/Cosmetics03/23/2023Voluntary Action Indicated (VAI)
OB USA, Inc.Food/Cosmetics03/06/2023No Action Indicated (NAI)
OC Snacks Sweets & TreatsFood/Cosmetics12/06/2023Voluntary Action Indicated (VAI)
Octapharma Plasma, Inc.Biologics08/15/2023No Action Indicated (NAI)
Old Fashioned Natural Products, Inc.Food/Cosmetics08/17/2023Voluntary Action Indicated (VAI)
Ondal Kimchi, Inc.Food/Cosmetics05/12/2023Voluntary Action Indicated (VAI)
Orange Bakery, Inc.Food/Cosmetics12/20/2023No Action Indicated (NAI)
Orange Lab, Inc.Drugs09/21/2023Voluntary Action Indicated (VAI)
Pacific Medical Group, Inc.Devices06/26/2023Voluntary Action Indicated (VAI)
Pacific Reproductive Center, Inc.Biologics08/31/2023Voluntary Action Indicated (VAI)
Packaging On Demand, Inc.Drugs01/13/2023Official Action Indicated (OAI)
PainDx, Inc.Devices01/19/2023No Action Indicated (NAI)
Paradyne Medical Products, Inc.Devices09/07/2023No Action Indicated (NAI)
Performance Research Laboratories, Inc.Food/Cosmetics08/17/2023Voluntary Action Indicated (VAI)
Productos Del Rancho La CofradiaFood/Cosmetics04/27/2023No Action Indicated (NAI)
Productos Mole Rojo Victoria USAFood/Cosmetics02/08/2023Voluntary Action Indicated (VAI)
Pure Sales, Inc.Food/Cosmetics01/18/2023No Action Indicated (NAI)
Quality Produced, LLCFood/Cosmetics05/02/2023No Action Indicated (NAI)
R. L. Arons, Inc.Food/Cosmetics01/03/2023No Action Indicated (NAI)
R2 Tea 2, LLCFood/Cosmetics03/22/2023No Action Indicated (NAI)
Rha Trading, Inc.Food/Cosmetics08/07/2023No Action Indicated (NAI)
STIR Foods, LLCFood/Cosmetics07/20/2023Voluntary Action Indicated (VAI)
Sac Food Supplies, Inc.Food/Cosmetics03/08/2023Voluntary Action Indicated (VAI)
Sanam Foods, Inc.Food/Cosmetics11/15/2023No Action Indicated (NAI)
Sanitor CorporationDrugs04/14/2023Official Action Indicated (OAI)
Sanyo Foods Corporation Of AmericaFood/Cosmetics08/10/2023No Action Indicated (NAI)
School Produce, LLCFood/Cosmetics05/05/2023No Action Indicated (NAI)
Shepard Brothers, Inc.Food/Cosmetics03/20/2023No Action Indicated (NAI)
Shining Seas Imports, LLCFood/Cosmetics01/26/2023No Action Indicated (NAI)
Sj Tea CompanyFood/Cosmetics05/16/2023No Action Indicated (NAI)
Southern California Center for Reproductive MedicineBiologics01/20/2023Voluntary Action Indicated (VAI)
Southern California Center for Reproductive MedicineBiologics12/13/2023Voluntary Action Indicated (VAI)
Sperm Bank, Inc.Biologics09/29/2023Voluntary Action Indicated (VAI)
States Logistics Services, Inc.Food/Cosmetics01/09/2023No Action Indicated (NAI)
Suheung-America CorporationFood/Cosmetics05/24/2023No Action Indicated (NAI)
Synovo ProductionDevices10/02/2023Official Action Indicated (OAI)
Tan Hoang Huong Distribution, LLCFood/Cosmetics12/13/2023Voluntary Action Indicated (VAI)
The Company ManufacturingTobacco01/12/2023No Action Indicated (NAI)
The Schwartz E-LiquidTobacco01/30/2023No Action Indicated (NAI)
Tonic Scene CompanyFood/Cosmetics12/13/2023No Action Indicated (NAI)
Tox Laboratory, M.D.Biologics07/20/2023Voluntary Action Indicated (VAI)
Transfer Technology, Inc.Drugs04/28/2023Voluntary Action Indicated (VAI)
Trong Food InternationalFood/Cosmetics03/23/2023Voluntary Action Indicated (VAI)
Trong Food InternationalFood/Cosmetics04/11/2023Voluntary Action Indicated (VAI)
Truer Medical, Inc.Devices06/28/2023No Action Indicated (NAI)
Unique Distributors, Inc.Food/Cosmetics03/21/2023No Action Indicated (NAI)
United Samples, Inc.Food/Cosmetics10/12/2023No Action Indicated (NAI)
Vanlaw Food Products, Inc.Food/Cosmetics09/19/2023Voluntary Action Indicated (VAI)
Vertos Medical, Inc.Devices04/05/2023No Action Indicated (NAI)
Visvita CorporationFood/Cosmetics05/25/2023Voluntary Action Indicated (VAI)
Vitang Technology, LLCDevices01/31/2023Official Action Indicated (OAI)
Vitech Bio-Chem CorporationVeterinary02/06/2023No Action Indicated (NAI)
West Coast Fertility Centers, LLCBiologics06/05/2023Voluntary Action Indicated (VAI)
Westridge Laboratories, Inc.Devices01/18/2023Voluntary Action Indicated (VAI)
Wisetrade CorporationFood/Cosmetics02/15/2023Official Action Indicated (OAI)
Wisetrade CorporationFood/Cosmetics12/06/2023No Action Indicated (NAI)
Yakult U. Inc., S.A.Food/Cosmetics08/18/2023No Action Indicated (NAI)

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