East Lake Norman News

There were 12 companies in cities associated with Mecklenburg County that received FDA citations as a result of 12 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 33.3% increase over the number of companies cited in the previous year.

Of the 41 citations issued, the most common citations include:

• You did not develop an FSVP.
• Written MDR procedures have not been developed and implemented.
• Potential suppliers and contractors were not evaluated and selected based on their ability to meet specified requirements.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Devices sector.

Of the companies cited, 10 should take voluntary actions to correct their managing operations (83.3%). Additionally, one company had to take regulatory and/or administrative actions (8.3%).

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	Issue Cited
Bakkavor Foods USA, Inc.	Food and Cosmetics	02/24/2023	Equipment and utensils - Design and maintenance
Bakkavor Foods USA, Inc.	Food and Cosmetics	02/24/2023	Process preventive controls - Implement
Bakkavor Foods USA, Inc.	Food and Cosmetics	02/24/2023	Sanitation preventive controls - Appropriate (Adequate)
Bakkavor Foods USA, Inc.	Food and Cosmetics	02/24/2023	Critical control points
Bakkavor Foods USA, Inc.	Food and Cosmetics	02/24/2023	Sanitation monitoring
Charlotte Mecklenburg Hospital Authority	Biologics	05/18/2023	Procedures to meet core CTGP
Charlotte Mecklenburg Hospital Authority	Biologics	05/18/2023	Aseptic processing---cleaning, disinfecting
Charlotte Mecklenburg Hospital Authority	Biologics	05/18/2023	Monitoring--cross contamination, exposure to CD
Emage Medical, LLC	Devices	04/04/2023	Lack of Written MDR Procedures
Emage Medical, LLC	Devices	04/04/2023	Evaluation and Selection, Suppliers, Contractors, etc.
Emage Medical, LLC	Devices	04/04/2023	Lack of or inadequate procedures - Acceptance activities
Emage Medical, LLC	Devices	04/04/2023	Nonconforming product, Lack of or inadequate procedures
Emage Medical, LLC	Devices	04/04/2023	Lack of or inadequate procedures
Emage Medical, LLC	Devices	04/04/2023	Lack of or inadequate complaint procedures
Emage Medical, LLC	Devices	04/04/2023	Servicing - Lack of or inadequate procedures
Iacofano's Group, LLC	Food and Cosmetics	06/08/2023	Sanitary operations - Plant maintenance
Iacofano's Group, LLC	Food and Cosmetics	06/08/2023	Hazard analysis - Conducted
Life Sensing Instruments, Inc.	Devices	01/27/2023	Purchasing controls, Lack of or inadequate procedures
Orange Bakery, Inc.	Food and Cosmetics	05/18/2023	Hazard analysis - Identification of hazard
Orange Bakery, Inc.	Food and Cosmetics	05/18/2023	Supply-chain program - Implement
REACT Innovations	Devices	02/17/2023	Lack of Written MDR Procedures
REACT Innovations	Devices	02/17/2023	Management review - Lack of or inadequate procedures
REACT Innovations	Devices	02/17/2023	Quality audits - Lack of or inadequate procedures
REACT Innovations	Devices	02/17/2023	Purchasing controls, Lack of or inadequate procedures
REACT Innovations	Devices	02/17/2023	Documented evaluation
REACT Innovations	Devices	02/17/2023	Evaluation and Selection, Suppliers, Contractors, etc.
REACT Innovations	Devices	02/17/2023	Documentation
REACT Innovations	Devices	02/17/2023	Lack of or inadequate instructions
REACT Innovations	Devices	02/17/2023	Lack of or inadequate complaint procedures
Sol International, LLC	Food and Cosmetics	11/08/2023	Develop FSVP
Sree Nidhi, Corp.	Food and Cosmetics	07/18/2023	Develop FSVP
Summit Coffee Roasting Company, LLC.	Food and Cosmetics	01/10/2023	Sanitary operations - Plant maintenance
USA Facemask, LLC	Devices	03/17/2023	Evaluation and Selection, Suppliers, Contractors, etc.
USA Facemask, LLC	Devices	03/17/2023	Supplier notification of changes
USA Facemask, LLC	Devices	03/17/2023	Documentation
USA Facemask, LLC	Devices	03/17/2023	Documentation
Van Harvest Distribution, LLC.	Food and Cosmetics	03/30/2023	Sanitary operations - Plant maintenance
Van Harvest Distribution, LLC.	Food and Cosmetics	03/30/2023	Manufacturing, processing, packing, holding - Controls
Van Harvest Distribution, LLC.	Food and Cosmetics	03/30/2023	Hazard analysis
Van Harvest Distribution, LLC.	Food and Cosmetics	03/30/2023	HACCP training or qualification
Van Harvest Distribution, LLC.	Food and Cosmetics	03/30/2023	Sanitation monitoring