There were 13 companies in cities associated with Cuyahoga 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 13.3% decrease from the number of companies cited in the previous year.
Of the 55 citations issued, the most common citation was ‘Procedures have not been adequately established to control product that does not conform to specified requirements’.
Most of the companies cited were involved in the Devices sector.
Of the companies cited, 13 should take voluntary actions to correct their managing operations. Additionally, one company had to take regulatory and/or administrative actions (7.7%).
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 Cuyahoga County Cities and the Citations They Received in 2024
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Cleveland Airport System | Food and Cosmetics | 02/26/2024 | Prevention of contamination |
| Health-Mor, Inc. | Devices | 06/14/2024 | Label to bear a unique device identifier |
| Health-Mor, Inc. | Devices | 06/14/2024 | Design Validation – Risk analysis not performed/inadequate |
| Health-Mor, Inc. | Devices | 06/14/2024 | Purchasing controls, Lack of or inadequate procedures |
| Health-Mor, Inc. | Devices | 06/14/2024 | Nonconforming product, Lack of or inadequate procedures |
| Health-Mor, Inc. | Devices | 06/14/2024 | Lack of or inadequate procedures |
| Health-Mor, Inc. | Devices | 06/14/2024 | Documentation |
| Health-Mor, Inc. | Devices | 06/14/2024 | Lack of or inadequate complaint procedures |
| Herolds Salads, Inc. | Food and Cosmetics | 01/18/2024 | Sanitation preventive controls – Implement |
| Herolds Salads, Inc. | Food and Cosmetics | 01/18/2024 | Sanitation preventive controls – Appropriate (Adequate) |
| Herolds Salads, Inc. | Food and Cosmetics | 01/18/2024 | Process preventive controls – Record review |
| Herolds Salads, Inc. | Food and Cosmetics | 01/18/2024 | Supply-chain program – Implement |
| Herolds Salads, Inc. | Food and Cosmetics | 12/10/2024 | Process preventive controls – Implement |
| Herolds Salads, Inc. | Food and Cosmetics | 12/10/2024 | Sanitation preventive controls – Implement |
| I Am Well Holistic, Inc. | Food and Cosmetics | 05/28/2024 | Written procedures – holding |
| I Am Well Holistic, Inc. | Food and Cosmetics | 05/28/2024 | Production, process controls – implement |
| I Am Well Holistic, Inc. | Food and Cosmetics | 05/28/2024 | Specifications – component identity |
| I Am Well Holistic, Inc. | Food and Cosmetics | 05/28/2024 | Specifications-component purity, strength, composition |
| I Am Well Holistic, Inc. | Food and Cosmetics | 05/28/2024 | Specifications – contamination limits |
| I Am Well Holistic, Inc. | Food and Cosmetics | 05/28/2024 | Specifications – contamination limits |
| I Am Well Holistic, Inc. | Food and Cosmetics | 05/28/2024 | Specifications – identity, purity, strength, composition |
| I Am Well Holistic, Inc. | Food and Cosmetics | 05/28/2024 | Reserve sample – collect, hold |
| I Am Well Holistic, Inc. | Food and Cosmetics | 05/28/2024 | Written procedures – quality control operations |
| I Am Well Holistic, Inc. | Food and Cosmetics | 05/28/2024 | Written procedures – components |
| I Am Well Holistic, Inc. | Food and Cosmetics | 05/28/2024 | Written procedures – rejected components, packaging, labels |
| I Am Well Holistic, Inc. | Food and Cosmetics | 05/28/2024 | Master manufacturing record – unique formulation |
| I Am Well Holistic, Inc. | Food and Cosmetics | 05/28/2024 | Batch record – complete |
| I Am Well Holistic, Inc. | Food and Cosmetics | 05/28/2024 | Written procedures – labeling operations |
| I Am Well Holistic, Inc. | Food and Cosmetics | 05/28/2024 | Written procedures -packaging operations |
| I Am Well Holistic, Inc. | Food and Cosmetics | 05/28/2024 | Written procedures – product complaint |
| National Foods Packaging Incorporated | Food and Cosmetics | 08/30/2024 | Hazard analysis – Conducted |
| Norman Noble, Inc. | Devices | 12/19/2024 | Environmental control Lack of or inadequate procedures |
| Norman Noble, Inc. | Devices | 12/19/2024 | Lack of or inadequate process validation |
| Pemco, Inc. | Devices | 10/25/2024 | Supplier oversight |
| Rhinosystems, Inc. | Devices | 02/08/2024 | Purchasing controls, Lack of or inadequate procedures |
| Rhinosystems, Inc. | Devices | 02/08/2024 | Nonconforming product, Lack of or inadequate procedures |
| Rhinosystems, Inc. | Devices | 02/08/2024 | Lack of or inadequate procedures |
| Rhinosystems, Inc. | Devices | 02/08/2024 | Lack of or inadequate complaint procedures |
| Technician Industries, Inc. | Devices | 09/03/2024 | Lack of or inadequate process validation |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Management review – defined interval, sufficient frequency |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Quality Audit/Reaudit – conducted |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Design Validation – Risk analysis not performed/inadequate |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Design history file |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Evaluation and Selection, Suppliers, Contractors, etc. |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Supplier oversight |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Acceptable supplier records, inadequate records |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Nonconforming product control |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Documentation |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Investigation of device failures |
| Viscus Biologics, LLC | Devices | 05/09/2024 | Design input – documentation |
| Viscus Biologics, LLC | Devices | 05/09/2024 | Design validation- Lack of or inadequate procedures |
| Viscus Biologics, LLC | Devices | 05/09/2024 | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| VisionAir Solutions, LLC | Devices | 03/14/2024 | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| VisionAir Solutions, LLC | Devices | 03/14/2024 | Nonconforming product, Lack of or inadequate procedures |
