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 |
