There were 14 companies in cities associated with Wake County that received FDA citations as a result of 14 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 12.5% decrease from the number of companies cited in the previous year.
Of the 68 citations issued, the most common citation was ‘Procedures for corrective and preventive action have not been adequately established’.
Most of the companies cited were involved in the Devices sector. The second most common type of company cited in the time period worked in the Biologics sector.
Of the companies cited, 13 should take voluntary actions to correct their managing operations (92.9%). Additionally, one company had to take regulatory and/or administrative actions (7.1%).
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.
According to its website, 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.
Companies Located Within Wake County Cities and the Citations They Received in 2024
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Amtai Medical Equipment, Inc. | Devices | 12/06/2024 | Individual Report of Malfunction |
| Amtai Medical Equipment, Inc. | Devices | 12/06/2024 | Lack of or inadequate procedures |
| Catalent Pharma Solutions, LLC | Biologics | 05/24/2024 | Cleaning / Sanitizing / Maintenance |
| Choice All Natural D, Inc. | Drugs | 02/26/2024 | Lack of quality control unit |
| Choice All Natural D, Inc. | Drugs | 02/26/2024 | Training–operations, GMPs, written procedures |
| Choice All Natural D, Inc. | Drugs | 02/26/2024 | Written sanitation procedures lacking |
| Choice All Natural D, Inc. | Drugs | 02/26/2024 | Buildings not maintained in good state of repair |
| Choice All Natural D, Inc. | Drugs | 02/26/2024 | Changes to Procedures Not Reviewed, Approved |
| Choice All Natural D, Inc. | Drugs | 02/26/2024 | In-process materials characteristics testing |
| Choice All Natural D, Inc. | Drugs | 02/26/2024 | Procedures for non-sterile drug products |
| Choice All Natural D, Inc. | Drugs | 02/26/2024 | Scientifically sound laboratory controls |
| Choice All Natural D, Inc. | Drugs | 02/26/2024 | Testing and release for distribution |
| Choice All Natural D, Inc. | Drugs | 02/26/2024 | Lack of written stability program |
| Choice All Natural D, Inc. | Drugs | 02/26/2024 | Items to cover on annual reviews |
| Choice All Natural D, Inc. | Drugs | 02/26/2024 | Prepared for each batch, include complete information |
| Choice All Natural D, Inc. | Drugs | 02/26/2024 | Procedures to be written and followed |
| Cryos International USA, LLC | Biologics | 03/22/2024 | Shipped but not kept in quarantine |
| GlaxoSmithKline, LLC | Drugs | 04/19/2024 | Complaint Handling Procedure |
| Indivior Manufacturing, LLC | Biologics | 01/18/2024 | Procedures not in writing, fully followed |
| Indivior Manufacturing, LLC | Biologics | 01/18/2024 | Training , Education , Experience overall |
| Indivior Manufacturing, LLC | Biologics | 01/18/2024 | Calibration/Inspection/Checking not done |
| Indivior Manufacturing, LLC | Biologics | 01/18/2024 | SOPs not followed / documented |
| Indivior Manufacturing, LLC | Biologics | 01/18/2024 | Validation lacking for sterile drug products |
| Indivior Manufacturing, LLC | Biologics | 01/18/2024 | Investigations of discrepancies, failures |
| Neomonde Baking Company | Food and Cosmetics | 08/16/2024 | Manufacturing, processing, packing, holding – Controls |
| Novartis Gene Therapies, Inc. | Biologics | 01/26/2024 | Extent of discrepancy, failure investigations |
| Novartis Gene Therapies, Inc. | Biologics | 01/26/2024 | When to report |
| Precision Diabetes, Inc. | Devices | 03/08/2024 | Management review – Lack of or inadequate procedures |
| Precision Diabetes, Inc. | Devices | 03/08/2024 | Quality Audits – defined intervals |
| Precision Diabetes, Inc. | Devices | 03/08/2024 | Design control – no procedures |
| Precision Diabetes, Inc. | Devices | 03/08/2024 | Evaluation of suppliers, contractors, etc., requirements |
| Precision Diabetes, Inc. | Devices | 03/08/2024 | Lack of or inadequate procedures – Acceptance activities |
| Precision Diabetes, Inc. | Devices | 03/08/2024 | Nonconforming product, Lack of or inadequate procedures |
| Precision Diabetes, Inc. | Devices | 03/08/2024 | Lack of or inadequate procedures |
| Q-Power Incorporated | Food and Cosmetics | 09/24/2024 | Evaluation – performance, risk |
| Q-Power Incorporated | Food and Cosmetics | 09/24/2024 | Approved supplier procedures – importer established |
| Q-Power Incorporated | Food and Cosmetics | 09/24/2024 | Supplier verification – establish written procedures |
| Q-Power Incorporated | Food and Cosmetics | 09/24/2024 | Verification activity assurance |
| Q-Power Incorporated | Food and Cosmetics | 09/24/2024 | Verification activity before import, periodically |
| Revian, Inc. | Devices | 03/22/2024 | Design verification – output does not meet input requirement |
| Revian, Inc. | Devices | 03/22/2024 | Design Validation – Risk analysis not performed/inadequate |
| Revian, Inc. | Devices | 03/22/2024 | Evaluation of suppliers, contractors, etc., requirements |
| Revian, Inc. | Devices | 03/22/2024 | Equipment control activity documentation |
| Revian, Inc. | Devices | 03/22/2024 | Nonconforming product, Lack of or inadequate procedures |
| Revian, Inc. | Devices | 03/22/2024 | Lack of or inadequate procedures |
| Revian, Inc. | Devices | 03/22/2024 | Complaints |
| Revian, Inc. | Devices | 03/22/2024 | Devices subject to device identification GUDID data submission requirements. |
| Suntech Medical, Inc. | Devices | 05/22/2024 | Evaluation of suppliers, contractors, etc., requirements |
| Suntech Medical, Inc. | Devices | 05/22/2024 | Lack of or inadequate procedures – Acceptance activities |
| Suntech Medical, Inc. | Devices | 05/22/2024 | Nonconforming product, Lack of or inadequate procedures |
| Suntech Medical, Inc. | Devices | 05/22/2024 | Lack of or inadequate procedures |
| Suntech Medical, Inc. | Devices | 05/22/2024 | Lack of or inadequate complaint procedures |
| WakeMed IRB | Biologics | 04/29/2024 | Initial and continuing reviews |
| WakeMed IRB | Biologics | 04/29/2024 | Minutes of IRB meetings |
| WakeMed IRB | Biologics | 04/29/2024 | List of members |
| WakeMed IRB | Devices | 04/29/2024 | Initial and continuing reviews |
| WakeMed IRB | Devices | 04/29/2024 | Minutes of IRB meetings |
| WakeMed IRB | Devices | 04/29/2024 | List of members |
| WakeMed IRB | Drugs | 04/29/2024 | Initial and continuing reviews |
| WakeMed IRB | Drugs | 04/29/2024 | Minutes of IRB meetings |
| WakeMed IRB | Drugs | 04/29/2024 | List of members |
| restor3d, Inc. | Devices | 06/14/2024 | Design verification – output does not meet input requirement |
| restor3d, Inc. | Devices | 06/14/2024 | Evaluation of suppliers, contractors, etc., requirements |
| restor3d, Inc. | Devices | 06/14/2024 | Production and Process Change Procedures, lack of or Inad. |
| restor3d, Inc. | Devices | 06/14/2024 | Lack of or inadequate procedures – Acceptance activities |
| restor3d, Inc. | Devices | 06/14/2024 | Nonconforming product, Lack of or inadequate procedures |
| restor3d, Inc. | Devices | 06/14/2024 | Labeling inspection – UDI |
| restor3d, Inc. | Devices | 06/14/2024 | DHR – not or inadequately maintained |
