How many companies in cities in Santa Clara County received FDA inspections in 2023?

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA - Official Website
DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA - Official Website
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There were 70 companies in cities associated with Santa Clara County, California, that received 71 FDA inspections in 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 27.3% increase over the number of companies inspected in the previous year, when 55 companies were inspected through 56 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 42 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (60%). 27 should take voluntary action to correct the organization’s management operations (38.6%). Additionally, two companies had to take regulatory and/or administrative actions (2.9%).

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 Santa Clara County and Their Inspection Results
Company Name Area of Business Inspection Date Result
AVI Trade, Corp. Food/Cosmetics 05/03/2023 No Action Indicated (NAI)
Air 7 Seas Transport Logistics, Inc. Food/Cosmetics 05/24/2023 No Action Indicated (NAI)
Air Chef, Inc. Food/Cosmetics 01/10/2023 No Action Indicated (NAI)
Ami Jayant Shah, M.D. Biologics 09/21/2023 No Action Indicated (NAI)
Anh Son Bakery Food/Cosmetics 02/15/2023 No Action Indicated (NAI)
Asap Sons Group, Inc. Food/Cosmetics 06/23/2023 Voluntary Action Indicated (VAI)
Asiana Produce, Inc. Food/Cosmetics 03/30/2023 Voluntary Action Indicated (VAI)
Avantec Vascular Corporation Devices 01/26/2023 Voluntary Action Indicated (VAI)
BLANSH INTERNATIONAL, Inc. Food/Cosmetics 06/09/2023 No Action Indicated (NAI)
BellArte Group Productions, LLC Food/Cosmetics 08/10/2023 No Action Indicated (NAI)
Bigfoot Biomedical Devices 03/21/2023 Voluntary Action Indicated (VAI)
BioCardia, Inc. Devices 04/10/2023 No Action Indicated (NAI)
Bondsforever, Inc. Food/Cosmetics 02/06/2023 Voluntary Action Indicated (VAI)
Cardiva Medical, Inc. Devices 07/21/2023 Voluntary Action Indicated (VAI)
Chef’s Choice Produce Company, LLC Food/Cosmetics 05/17/2023 No Action Indicated (NAI)
Cirtec Medical Devices 03/08/2023 Voluntary Action Indicated (VAI)
Curatia Medical Company Devices 12/04/2023 No Action Indicated (NAI)
Del Fresh Produce, Inc. Food/Cosmetics 04/03/2023 No Action Indicated (NAI)
Embolx, Inc. Devices 01/19/2023 Voluntary Action Indicated (VAI)
Evershing International Trading, Inc. Food/Cosmetics 09/08/2023 Voluntary Action Indicated (VAI)
Food Market Management, Inc. Food/Cosmetics 05/16/2023 No Action Indicated (NAI)
Frantoio Grove Food/Cosmetics 11/06/2023 No Action Indicated (NAI)
Gordon Biersch Brewing Company Food/Cosmetics 03/08/2023 No Action Indicated (NAI)
Gordon Biersch Brewing Company Veterinary 03/08/2023 No Action Indicated (NAI)
Grandy Ventures, Inc. Food/Cosmetics 08/17/2023 Voluntary Action Indicated (VAI)
GreenTripe.com, Inc. Veterinary 09/06/2023 Voluntary Action Indicated (VAI)
Greet Well, Inc. Food/Cosmetics 06/06/2023 No Action Indicated (NAI)
Gregory B. Hammer, M.D. Drugs 03/15/2023 No Action Indicated (NAI)
Gruma Corporation Food/Cosmetics 06/15/2023 No Action Indicated (NAI)
HP Food Supply Food/Cosmetics 06/06/2023 No Action Indicated (NAI)
Intuitive Surgical, Inc. Devices 12/14/2023 Voluntary Action Indicated (VAI)
Jalimex Foods, Corp. Food/Cosmetics 06/05/2023 No Action Indicated (NAI)
Janice Wes Brown, M.D. Biologics 03/29/2023 No Action Indicated (NAI)
Jason T. Gotlib, M.D. Drugs 02/17/2023 No Action Indicated (NAI)
L&D Fish Corporation Food/Cosmetics 08/18/2023 Voluntary Action Indicated (VAI)
LimFlow, Inc. Devices 05/15/2023 Voluntary Action Indicated (VAI)
Lucile Salter Packard Children’s Hospital Stanford Medicine Fertility and Reproductive Health Biologics 04/27/2023 Voluntary Action Indicated (VAI)
Mai, PHU Van Food/Cosmetics 05/24/2023 Voluntary Action Indicated (VAI)
Meditrina Devices 02/23/2023 No Action Indicated (NAI)
Mona Foods Food/Cosmetics 03/27/2023 No Action Indicated (NAI)
Morning Bird, Inc. Veterinary 09/06/2023 No Action Indicated (NAI)
North Coast Medical, Inc. Devices 08/28/2023 Voluntary Action Indicated (VAI)
OMNILIFE USA, Inc. Food/Cosmetics 04/28/2023 Voluntary Action Indicated (VAI)
Ocomar Enterprises, LLC Food/Cosmetics 08/18/2023 Voluntary Action Indicated (VAI)
Ostial Corporation Devices 01/12/2023 No Action Indicated (NAI)
Outset Medical, Inc. Devices 02/10/2023 Official Action Indicated (OAI)
Outset Medical, Inc. Devices 02/10/2023 Voluntary Action Indicated (VAI)
Palo Alto Medical Foundation Fertility Physicians of Northern California Biologics 05/10/2023 No Action Indicated (NAI)
Paramit a Tecan Group Company Devices 01/18/2023 No Action Indicated (NAI)
Phoenix Deventures Devices 02/15/2023 Voluntary Action Indicated (VAI)
R & J Toffees, LLC Food/Cosmetics 10/20/2023 No Action Indicated (NAI)
Relign, Corp. Devices 05/17/2023 Voluntary Action Indicated (VAI)
Robles Bros, Inc. Food/Cosmetics 05/18/2023 Voluntary Action Indicated (VAI)
SFTC, Inc. Food/Cosmetics 06/23/2023 Voluntary Action Indicated (VAI)
SFTC, Inc. Food/Cosmetics 11/28/2023 Voluntary Action Indicated (VAI)
Sai Foods, Inc. Food/Cosmetics 02/06/2023 Voluntary Action Indicated (VAI)
Santa Clara Nut Company Food/Cosmetics 03/30/2023 No Action Indicated (NAI)
Second Source Medical, LLC Devices 02/03/2023 No Action Indicated (NAI)
Sheathing Technologies, Inc. Devices 08/02/2023 No Action Indicated (NAI)
Silk Road Medical, Inc. Devices 10/18/2023 No Action Indicated (NAI)
Sonny Produce Food/Cosmetics 03/31/2023 No Action Indicated (NAI)
Stanford University Research Compliance Office Biologics 08/07/2023 No Action Indicated (NAI)
Stanford University Research Compliance Office Drugs 08/07/2023 No Action Indicated (NAI)
Stellartech Research Corporation Devices 03/29/2023 No Action Indicated (NAI)
Sunny Egg Company, Inc. Food/Cosmetics 08/04/2023 No Action Indicated (NAI)
T & S Produce Company, Inc. Food/Cosmetics 03/01/2023 Voluntary Action Indicated (VAI)
T & V Wholesale Food, Inc. Food/Cosmetics 06/05/2023 No Action Indicated (NAI)
Tenon Medical, Inc. Devices 11/01/2023 No Action Indicated (NAI)
Theos Medical Systems, Inc. Devices 06/16/2023 Official Action Indicated (OAI)
Verka USA, Inc. Food/Cosmetics 05/01/2023 Voluntary Action Indicated (VAI)
Veterans Affairs Health Care System Transfusion Service Biologics 02/23/2023 No Action Indicated (NAI)
Vita Imaging, Inc. Devices 07/26/2023 No Action Indicated (NAI)
Vivus, Inc. Drugs 09/08/2023 No Action Indicated (NAI)
Wyzen Foods, Inc. Food/Cosmetics 06/14/2023 No Action Indicated (NAI)


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