46 companies in cities within Wake County received 49 inspections in 2023

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
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There were 46 companies in cities associated with Wake County, North Carolina, that received 49 FDA inspections in 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 4.2% decrease from the number of companies inspected in the previous year, when 48 companies were inspected through 48 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 Drugs sector.

There were 31 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (67.4%). 15 should take voluntary action to correct the organization’s management operations (32.6%).

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.

Companies Located in Cities Within Wake County and Their Inspection Results
Company Name Area of Business Inspection Date Result
623 Medical, LLC Devices 08/10/2023 No Action Indicated (NAI)
Ablexan Corporation Devices 01/23/2023 No Action Indicated (NAI)
Alcami Carolinas Corporation Drugs 03/13/2023 Voluntary Action Indicated (VAI)
Allison K. Ross, M.D. Drugs 02/16/2023 No Action Indicated (NAI)
American Red Cross Blood Services Biologics 10/16/2023 Voluntary Action Indicated (VAI)
AmerisourceBergen Drug Corporation Food/Cosmetics 06/15/2023 Voluntary Action Indicated (VAI)
Aramark Refreshment Services- Raleigh Food/Cosmetics 06/15/2023 No Action Indicated (NAI)
Atlantic Fertility Center Partners, LLC Biologics 01/11/2023 No Action Indicated (NAI)
Avioq, Inc. Biologics 12/05/2023 Voluntary Action Indicated (VAI)
Blood Connection, Inc. Biologics 06/23/2023 No Action Indicated (NAI)
CSL Plasma, Inc. Biologics 07/21/2023 No Action Indicated (NAI)
Cardinal Health, Inc. Food/Cosmetics 09/14/2023 No Action Indicated (NAI)
Carolina Conceptions, PA Biologics 06/01/2023 Voluntary Action Indicated (VAI)
CivaTech Oncology, Inc. Devices 06/14/2023 Voluntary Action Indicated (VAI)
Clear Choice Therapeutics, Inc. Devices 05/11/2023 Voluntary Action Indicated (VAI)
Cristina Gasparetto, M.D. Drugs 09/29/2023 No Action Indicated (NAI)
Deep Blue Medical Advances, Inc. Devices 05/18/2023 No Action Indicated (NAI)
Durham Exchange Club Industries, Inc. Tobacco 02/21/2023 No Action Indicated (NAI)
Edward C. Smith, M.D. Drugs 03/17/2023 No Action Indicated (NAI)
Epiphany Craft Malt Food/Cosmetics 05/16/2023 No Action Indicated (NAI)
GlacierPoint Enterprises – Carolinas Food/Cosmetics 07/20/2023 Voluntary Action Indicated (VAI)
IQVIA Biotech Drugs 04/27/2023 No Action Indicated (NAI)
JMD Marketing, Inc. Food/Cosmetics 09/19/2023 No Action Indicated (NAI)
Jad Walters, Ph. D. Devices 09/06/2023 No Action Indicated (NAI)
Ladyfingers Catering, LLC Food/Cosmetics 08/09/2023 No Action Indicated (NAI)
Lalilab, Inc. Food/Cosmetics 03/27/2023 No Action Indicated (NAI)
Luminelle, Inc. Devices 02/21/2023 Voluntary Action Indicated (VAI)
Merz North America, Inc. Devices 06/22/2023 No Action Indicated (NAI)
North Carolina Center for Reproductive Medicine, Inc. Biologics 01/26/2023 Voluntary Action Indicated (VAI)
North Carolina State University Dairy Plant Food/Cosmetics 06/29/2023 No Action Indicated (NAI)
North Lily Foods, Inc. Food/Cosmetics 10/23/2023 Voluntary Action Indicated (VAI)
Novan, Inc. Drugs 06/07/2023 No Action Indicated (NAI)
Premier Research and Consulting Drugs 05/17/2023 No Action Indicated (NAI)
R & H Produce, Inc. Food/Cosmetics 05/17/2023 No Action Indicated (NAI)
SpringWorks Therapeutics, Inc. Drugs 03/31/2023 Voluntary Action Indicated (VAI)
Sweetbottoms Naturals, LLC Food/Cosmetics 11/08/2023 Voluntary Action Indicated (VAI)
Syneos Health Drugs 02/02/2023 No Action Indicated (NAI)
Syneos Health Drugs 07/13/2023 No Action Indicated (NAI)
Syneos Health Drugs 08/31/2023 No Action Indicated (NAI)
Syneos Health Drugs 12/13/2023 No Action Indicated (NAI)
The ICEE Company Food/Cosmetics 04/04/2023 No Action Indicated (NAI)
Thomas L. Ortel, M.D. Biologics 07/17/2023 No Action Indicated (NAI)
UCB Biosciences, Inc. Drugs 03/24/2023 No Action Indicated (NAI)
UPS Supply Chain Solutions, Inc. Drugs 06/29/2023 No Action Indicated (NAI)
Vector Tobacco, LLC Tobacco 08/09/2023 No Action Indicated (NAI)
Veloxis Pharmaceuticals, Inc. Drugs 05/19/2023 No Action Indicated (NAI)
Wards Fruit & Produce Company Food/Cosmetics 01/10/2023 No Action Indicated (NAI)
WatchChild, LLC Devices 12/13/2023 Voluntary Action Indicated (VAI)
restor3d, Inc. Devices 05/12/2023 Voluntary Action Indicated (VAI)


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