Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is a 47.4% increase over the number of companies inspected in the previous quarter, when 19 companies received 19 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 15 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (53.6%). 12 should take voluntary action to correct the organization's management operations (42.9%). Additionally, one company had to take regulatory and/or administrative actions (3.6%).
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 |
---|---|---|---|
4 Aces Import, Inc. | Food and Cosmetics | 02/10/2023 | No Action Indicated (NAI) |
Action Imports LP | Food and Cosmetics | 01/19/2023 | No Action Indicated (NAI) |
Advanced Infusion Solutions | Drugs | 01/30/2023 | Voluntary Action Indicated (VAI) |
AdvoCare International, LLC | Food and Cosmetics | 01/20/2023 | No Action Indicated (NAI) |
Baylor Institute For Immunology | Biologics | 03/01/2023 | No Action Indicated (NAI) |
BioLife Plasma Services L. P. | Biologics | 03/23/2023 | No Action Indicated (NAI) |
Carter BloodCare Irving, TX Donor Center | Biologics | 02/09/2023 | No Action Indicated (NAI) |
DFA Dairy Brands Fluid, LLC | Food and Cosmetics | 01/25/2023 | No Action Indicated (NAI) |
Dhaliwal Laboratories, LLC | Veterinary | 02/07/2023 | Voluntary Action Indicated (VAI) |
El Gordo Spices, LLC | Food and Cosmetics | 03/22/2023 | Voluntary Action Indicated (VAI) |
Essendant Company | Food and Cosmetics | 02/22/2023 | No Action Indicated (NAI) |
Ethen Foods USA, Inc. | Food and Cosmetics | 02/06/2023 | No Action Indicated (NAI) |
Fruit Of The Earth Research Laboratories, Inc. | Drugs | 03/31/2023 | Voluntary Action Indicated (VAI) |
Genesis Biosystems, Inc. | Devices | 01/09/2023 | Voluntary Action Indicated (VAI) |
InReach Convenient Solutions | Food and Cosmetics | 03/06/2023 | Voluntary Action Indicated (VAI) |
Kevala International, LLC | Food and Cosmetics | 01/17/2023 | Voluntary Action Indicated (VAI) |
LinkEx, Inc. | Food and Cosmetics | 01/09/2023 | No Action Indicated (NAI) |
Melinda's Foods, LLC | Food and Cosmetics | 01/12/2023 | Voluntary Action Indicated (VAI) |
Orthofix U. S., LLC | Devices | 03/17/2023 | Voluntary Action Indicated (VAI) |
Performance Food Group, Inc. | Food and Cosmetics | 01/10/2023 | No Action Indicated (NAI) |
Restaurant Depot | Food and Cosmetics | 01/20/2023 | No Action Indicated (NAI) |
Scott R. Bartley, M.D. | Drugs | 02/17/2023 | Voluntary Action Indicated (VAI) |
Southwest Airlines | Food and Cosmetics | 01/25/2023 | No Action Indicated (NAI) |
Southwest Transplant Alliance, Inc. | Biologics | 02/03/2023 | No Action Indicated (NAI) |
Taka USA, Inc. | Drugs | 02/07/2023 | Official Action Indicated (OAI) |
Unifi Aviation, LLC | Food and Cosmetics | 01/25/2023 | Voluntary Action Indicated (VAI) |
University of Texas Southwestern Medical Center, The | Devices | 02/09/2023 | No Action Indicated (NAI) |
Xochitl Gourmet Foods, LLC | Food and Cosmetics | 01/25/2023 | Voluntary Action Indicated (VAI) |