Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
This is a 5.7% increase over the number of companies inspected in the previous year, when 35 companies were inspected through 35 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 18 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (48.6%). 18 should take voluntary action to correct the organization's management operations (48.6%). Additionally, one company had to take regulatory and/or administrative actions (2.7%).
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 |
|---|---|---|---|
| Affiliated Imports, LLC | Tobacco | 08/03/2023 | No Action Indicated (NAI) |
| American Airlines | Food/Cosmetics | 09/14/2023 | Voluntary Action Indicated (VAI) |
| Aspire Fertility Institute Austin | Biologics | 12/19/2023 | No Action Indicated (NAI) |
| Atlantic Aviation, LLC | Food/Cosmetics | 09/13/2023 | No Action Indicated (NAI) |
| Austin's Natural Frozen Pops, Inc. | Food/Cosmetics | 10/24/2023 | Voluntary Action Indicated (VAI) |
| Bliss Foods, LLC | Food/Cosmetics | 01/10/2023 | Voluntary Action Indicated (VAI) |
| Bobalu Cigar Company Austin, Inc. | Tobacco | 04/04/2023 | No Action Indicated (NAI) |
| CSL Plasma, Inc. | Biologics | 11/02/2023 | No Action Indicated (NAI) |
| CieloWorks, Inc. | Biologics | 08/18/2023 | Voluntary Action Indicated (VAI) |
| Ensemble Orthopedics, Inc. | Devices | 08/04/2023 | Voluntary Action Indicated (VAI) |
| G Surgical, LLC | Devices | 03/01/2023 | Voluntary Action Indicated (VAI) |
| Genesys Orthopedics Systems, LLC | Devices | 08/10/2023 | No Action Indicated (NAI) |
| Isik Organic Company | Food/Cosmetics | 09/20/2023 | No Action Indicated (NAI) |
| Linde Gas & Equipment, Inc. | Food/Cosmetics | 03/07/2023 | No Action Indicated (NAI) |
| Lindsay Harrison, M.D. | Devices | 10/05/2023 | No Action Indicated (NAI) |
| Lsg Sky Chefs, Inc. | Food/Cosmetics | 09/18/2023 | Voluntary Action Indicated (VAI) |
| Luminex Corporation | Devices | 01/13/2023 | Voluntary Action Indicated (VAI) |
| Miracles In Sight Lone Star Division | Biologics | 03/10/2023 | No Action Indicated (NAI) |
| Nulo, Inc. | Veterinary | 12/15/2023 | No Action Indicated (NAI) |
| Orange Traders, LLC | Food/Cosmetics | 04/11/2023 | Voluntary Action Indicated (VAI) |
| Organicare Nature's Science, LLC | Drugs | 12/01/2023 | Voluntary Action Indicated (VAI) |
| Ozark Bottled Water | Food/Cosmetics | 01/23/2023 | No Action Indicated (NAI) |
| Pastel Cartel, LLC | Tobacco | 08/03/2023 | Voluntary Action Indicated (VAI) |
| Reddy Ice | Food/Cosmetics | 01/24/2023 | No Action Indicated (NAI) |
| Robert Wong, M.D. | Drugs | 05/04/2023 | No Action Indicated (NAI) |
| Shantaba, LLC | Food/Cosmetics | 07/07/2023 | Official Action Indicated (OAI) |
| Sky Marketing, Corp. | Food/Cosmetics | 04/13/2023 | Voluntary Action Indicated (VAI) |
| SpineSmith Holdings, LLC | Devices | 08/01/2023 | Voluntary Action Indicated (VAI) |
| Texafrance, Inc. | Food/Cosmetics | 12/06/2023 | Voluntary Action Indicated (VAI) |
| Texas Department of State Health Services IRB | Drugs | 03/10/2023 | No Action Indicated (NAI) |
| Texas Sweet Heat Jam Company | Food/Cosmetics | 12/08/2023 | Voluntary Action Indicated (VAI) |
| Tiff's Treats RBD | Food/Cosmetics | 01/20/2023 | Voluntary Action Indicated (VAI) |
| Transunion Fresh, Corp. | Food/Cosmetics | 02/08/2023 | No Action Indicated (NAI) |
| Vincent A. Restivo | Drugs | 05/26/2023 | Voluntary Action Indicated (VAI) |
| Virtex | Devices | 08/02/2023 | No Action Indicated (NAI) |
| We are Blood | Biologics | 10/24/2023 | No Action Indicated (NAI) |
| Westlake IVF, LLC | Biologics | 12/11/2023 | Voluntary Action Indicated (VAI) |
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