East Lake Norman News

There were 12 companies in cities associated with Mecklenburg County, North Carolina, that received 12 FDA inspections in the second quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 20% decrease from 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 Biologics sector. The second most common type of company inspected worked in the Food and Cosmetics sector.

There were nine companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (75%). Three should take voluntary action to correct their management operations (25%).

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
American Red Cross Blood Services Carolinas Region	Biologics	05/03/2023	No Action Indicated (NAI)
Birth Tissue Recovery, LLC	Biologics	05/09/2023	No Action Indicated (NAI)
CSL Plasma, Inc.	Biologics	05/25/2023	No Action Indicated (NAI)
Canteen Charlotte	Food and Cosmetics	05/04/2023	No Action Indicated (NAI)
Charlotte Mecklenburg Hospital Authority	Biologics	05/18/2023	Voluntary Action Indicated (VAI)
Emage Medical, LLC	Devices	04/04/2023	Voluntary Action Indicated (VAI)
Mohammad R. Bolouri, M.D.	Drugs	04/04/2023	No Action Indicated (NAI)
NoDa Brewing Company	Food and Cosmetics	06/28/2023	No Action Indicated (NAI)
NoDa Brewing Company	Veterinary	06/28/2023	No Action Indicated (NAI)
Orange Bakery, Inc.	Food and Cosmetics	05/18/2023	Voluntary Action Indicated (VAI)
Reproductive Endocrinology Associates of Charlotte	Biologics	05/11/2023	No Action Indicated (NAI)
Reproductive Specialists of the Carolinas	Biologics	05/04/2023	No Action Indicated (NAI)
The Program for Assisted Reproduction at Atrium Health's Carolinas Medical Center	Biologics	05/10/2023	No Action Indicated (NAI)