Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
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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