Vid Desai FDA’s Chief Information Officer | Official Website
Vid Desai FDA’s Chief Information Officer | Official Website
This is a 66.7% increase over the number of companies inspected in the previous quarter, when 15 companies received 15 inspections.
Most of the companies inspected at the time were involved in the Devices sector. The second most common type of company inspected worked in the Food and Cosmetics sector.
There were 15 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (60%). 10 should take voluntary action to correct the organization's management operations (40%). Additionally, one company had to take regulatory and/or administrative actions (4%).
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.
| Company Name | Area of Business | Inspection Date | Result |
|---|---|---|---|
| Air Chef, Inc. | Food and Cosmetics | 01/10/2023 | No Action Indicated (NAI) |
| Anh Son Bakery | Food and Cosmetics | 02/15/2023 | No Action Indicated (NAI) |
| Asiana Produce, Inc. | Food and Cosmetics | 03/30/2023 | Voluntary Action Indicated (VAI) |
| Avantec Vascular Corporation | Devices | 01/26/2023 | Voluntary Action Indicated (VAI) |
| Bigfoot Biomedical | Devices | 03/21/2023 | Voluntary Action Indicated (VAI) |
| Bondsforever, Inc. | Food and Cosmetics | 02/06/2023 | Voluntary Action Indicated (VAI) |
| Cirtec Medical | Devices | 03/08/2023 | Voluntary Action Indicated (VAI) |
| Embolx, Inc. | Devices | 01/19/2023 | Voluntary Action Indicated (VAI) |
| Gordon Biersch Brewing Company | Food and Cosmetics | 03/08/2023 | No Action Indicated (NAI) |
| Gordon Biersch Brewing Company | Veterinary | 03/08/2023 | No Action Indicated (NAI) |
| Gregory B. Hammer, M.D. | Drugs | 03/15/2023 | 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) |
| Meditrina | Devices | 02/23/2023 | No Action Indicated (NAI) |
| Mona Foods | Food and Cosmetics | 03/27/2023 | No Action Indicated (NAI) |
| 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) |
| Paramit a Tecan Group Company | Devices | 01/18/2023 | No Action Indicated (NAI) |
| Phoenix Deventures | Devices | 02/15/2023 | Voluntary Action Indicated (VAI) |
| Sai Foods, Inc. | Food and Cosmetics | 02/06/2023 | Voluntary Action Indicated (VAI) |
| Santa Clara Nut Company | Food and Cosmetics | 03/30/2023 | No Action Indicated (NAI) |
| Second Source Medical, LLC | Devices | 02/03/2023 | No Action Indicated (NAI) |
| Sonny Produce | Food and Cosmetics | 03/31/2023 | No Action Indicated (NAI) |
| Stellartech Research Corporation | Devices | 03/29/2023 | No Action Indicated (NAI) |
| T & S Produce Company, Inc. | Food and Cosmetics | 03/01/2023 | Voluntary Action Indicated (VAI) |
| Veterans Affairs Health Care System Transfusion Service | Biologics | 02/23/2023 | No Action Indicated (NAI) |
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