Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is a 33.3% increase over the number of companies inspected in the previous quarter, when 36 companies received 36 inspections.
Most of the companies inspected at the time were involved in the Food and Cosmetics sector. Both the Drugs and Biologics sectors sectors tied for second most common type.
There were 22 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (45.8%). 25 should take voluntary action to correct the organization's management operations (52.1%). Additionally, one company had to take regulatory and/or administrative actions (2.1%).
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.
| Company Name | Area of Business | Inspection Date | Result |
|---|---|---|---|
| Allergan Sales, LLC | Drugs | 07/28/2023 | No Action Indicated (NAI) |
| Ari's Wholesale, LLC | Food and Cosmetics | 08/09/2023 | Voluntary Action Indicated (VAI) |
| Balt USA, LLC | Devices | 07/21/2023 | Voluntary Action Indicated (VAI) |
| Barohup, Inc. | Food and Cosmetics | 08/21/2023 | Voluntary Action Indicated (VAI) |
| Beverage Visions, LLC | Food and Cosmetics | 09/06/2023 | No Action Indicated (NAI) |
| Bread Artisan Bakery, Inc. | Food and Cosmetics | 08/18/2023 | Voluntary Action Indicated (VAI) |
| CVS Health, Inc. | Food and Cosmetics | 09/20/2023 | No Action Indicated (NAI) |
| Calmo Manufacturing, Inc. | Drugs | 08/04/2023 | No Action Indicated (NAI) |
| Citro Fresh, LLC | Food and Cosmetics | 08/28/2023 | Voluntary Action Indicated (VAI) |
| Clinical Resolution Laboratory, Inc. | Drugs | 09/29/2023 | Official Action Indicated (OAI) |
| Cloud 9 Distributors, LLC | Tobacco | 09/21/2023 | Voluntary Action Indicated (VAI) |
| Dang Vu, Inc. | Food and Cosmetics | 07/06/2023 | Voluntary Action Indicated (VAI) |
| Dendreon Pharmaceuticals, LLC | Biologics | 08/10/2023 | Voluntary Action Indicated (VAI) |
| Ehsan Sadri, M.D. | Drugs | 09/15/2023 | No Action Indicated (NAI) |
| Elite BioFusion, LLC | Biologics | 09/29/2023 | Voluntary Action Indicated (VAI) |
| Elly R. Lee, M.D. | Drugs | 08/16/2023 | No Action Indicated (NAI) |
| Fertility Center of Orange County, A Medical Group, Inc. | Biologics | 08/29/2023 | Voluntary Action Indicated (VAI) |
| First Biotech, Inc. | Food and Cosmetics | 09/14/2023 | Voluntary Action Indicated (VAI) |
| Genesis Biologics, Inc. | Biologics | 07/21/2023 | Voluntary Action Indicated (VAI) |
| Giulianos' Specialty Foods, Inc. | Food and Cosmetics | 09/05/2023 | No Action Indicated (NAI) |
| HCN Industries, Inc. | Food and Cosmetics | 08/16/2023 | Voluntary Action Indicated (VAI) |
| Hepatiq, Inc. | Devices | 07/12/2023 | No Action Indicated (NAI) |
| Houdini, Inc. | Food and Cosmetics | 08/24/2023 | No Action Indicated (NAI) |
| Joanna Van, M.D. | Drugs | 08/11/2023 | No Action Indicated (NAI) |
| Just Food For Dogs - Irvine | Veterinary | 07/26/2023 | No Action Indicated (NAI) |
| Lightmed USA, Inc. | Devices | 08/09/2023 | No Action Indicated (NAI) |
| MPS Pharma & Medical, Inc. | Devices | 07/28/2023 | No Action Indicated (NAI) |
| Majestic International Group | Food and Cosmetics | 08/01/2023 | No Action Indicated (NAI) |
| Maruchan, Inc. | Food and Cosmetics | 08/16/2023 | No Action Indicated (NAI) |
| Marukome USA, Inc. | Food and Cosmetics | 08/08/2023 | Voluntary Action Indicated (VAI) |
| Meta Dynamic Incorporated | Devices | 07/17/2023 | Voluntary Action Indicated (VAI) |
| Mettler Electronics Corporation | Devices | 09/14/2023 | Voluntary Action Indicated (VAI) |
| Misako Nagasaka, M.D. | Drugs | 07/14/2023 | No Action Indicated (NAI) |
| Nitto Avecia Pharma Services, Inc. | Veterinary | 09/22/2023 | Voluntary Action Indicated (VAI) |
| Nor-Cal Beverage Company, Inc. | Food and Cosmetics | 07/27/2023 | No Action Indicated (NAI) |
| Octapharma Plasma, Inc. | Biologics | 08/15/2023 | No Action Indicated (NAI) |
| Old Fashioned Natural Products, Inc. | Food and Cosmetics | 08/17/2023 | Voluntary Action Indicated (VAI) |
| Orange Lab, Inc. | Drugs | 09/21/2023 | Voluntary Action Indicated (VAI) |
| Pacific Reproductive Center, Inc. | Biologics | 08/31/2023 | Voluntary Action Indicated (VAI) |
| Paradyne Medical Products, Inc. | Devices | 09/07/2023 | No Action Indicated (NAI) |
| Performance Research Laboratories, Inc. | Food and Cosmetics | 08/17/2023 | Voluntary Action Indicated (VAI) |
| Rha Trading, Inc. | Food and Cosmetics | 08/07/2023 | No Action Indicated (NAI) |
| STIR Foods, LLC | Food and Cosmetics | 07/20/2023 | Voluntary Action Indicated (VAI) |
| Sanyo Foods Corporation Of America | Food and Cosmetics | 08/10/2023 | No Action Indicated (NAI) |
| Sperm Bank, Inc. | Biologics | 09/29/2023 | Voluntary Action Indicated (VAI) |
| Tox Laboratory, M.D. | Biologics | 07/20/2023 | Voluntary Action Indicated (VAI) |
| Vanlaw Food Products, Inc. | Food and Cosmetics | 09/19/2023 | Voluntary Action Indicated (VAI) |
| Yakult U. Inc., S.A. | Food and Cosmetics | 08/18/2023 | No Action Indicated (NAI) |
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