There were 12 companies in cities associated with Hamilton County that received FDA citations as a result of 12 inspections conducted in the county in 2025, according to 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 35 citations issued, the most common citation was ‘There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed’.
Most of the companies cited were involved in the Drugs sector. The second most common type of company operated in the Food and Cosmetics sector.
Of the companies cited, 11 should take voluntary actions to correct their managing operations (91.7%). 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.
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 and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Alexei A. Grom, M.D. | Drugs | 03/26/2025 | Record retention |
| Ashley L. Devonshire, MPH, M.D. | Drugs | 11/20/2025 | FD-1572, protocol compliance |
| Ashley L. Devonshire, MPH, M.D. | Drugs | 11/20/2025 | Case history records- inadequate or inadequate |
| Band Connect | Devices | 12/12/2025 | Management review – Lack of or inadequate procedures |
| Band Connect | Devices | 12/12/2025 | Design control – no procedures |
| Band Connect | Devices | 12/12/2025 | Lack of or inadequate procedures |
| Band Connect | Devices | 12/12/2025 | Lack of or inadequate complaint procedures |
| Hoxworth Blood Center University of Cincinnati | Biologics | 09/08/2025 | Establish, maintain and follow manufacturing SOPs |
| Hoxworth Blood Center University of Cincinnati | Biologics | 09/08/2025 | Proof Of Identity |
| Jungle Jim’s Market, Inc. | Food and Cosmetics | 02/07/2025 | Develop FSVP |
| Kaiser Foods, Inc. | Food and Cosmetics | 08/07/2025 | Scheduled process |
| Kutol Products Company, Inc. | Drugs | 03/04/2025 | Procedures not in writing, fully followed |
| Kutol Products Company, Inc. | Drugs | 03/04/2025 | Written procedures not established/followed |
| Kutol Products Company, Inc. | Drugs | 03/04/2025 | Absence of Written Procedures |
| Kutol Products Company, Inc. | Drugs | 03/04/2025 | Scientifically sound laboratory controls |
| Kutol Products Company, Inc. | Drugs | 03/04/2025 | Microbiological testing |
| Kutol Products Company, Inc. | Drugs | 03/04/2025 | Investigations of discrepancies, failures |
| Kutol Products Company, Inc. | Drugs | 03/04/2025 | Second person sign off |
| Ohio Fertility Providers, LLC | Biologics | 05/15/2025 | Completion of eligibility determination |
| Ohio Fertility Providers, LLC | Biologics | 05/15/2025 | Eligibility not required–warning labels |
| Patheon Pharmaceuticals, Inc. | Drugs | 09/26/2025 | Procedures not in writing, fully followed |
| Patheon Pharmaceuticals, Inc. | Drugs | 09/26/2025 | Written procedures not established/followed |
| Patheon Pharmaceuticals, Inc. | Drugs | 09/26/2025 | Investigations of discrepancies, failures |
| Patheon Pharmaceuticals, Inc. | Veterinary | 09/26/2025 | Procedures not in writing, fully followed |
| Patheon Pharmaceuticals, Inc. | Veterinary | 09/26/2025 | Written procedures not established/followed |
| Patheon Pharmaceuticals, Inc. | Veterinary | 09/26/2025 | Investigations of discrepancies, failures |
| Q Labs, LLC | Drugs | 04/25/2025 | Investigations of discrepancies, failures |
| Q Labs, LLC | Drugs | 04/25/2025 | Second person sign off |
| Rocket Systems | Food and Cosmetics | 10/16/2025 | Quality control production, process control; material review, disposition |
| Rocket Systems | Food and Cosmetics | 10/16/2025 | Master manufacturing record – record requirements |
| Rocket Systems | Food and Cosmetics | 10/16/2025 | Batch record – required information |
| Spot Health, Inc. | Devices | 10/22/2025 | Label to bear a unique device identifier |
| Spot Health, Inc. | Devices | 10/22/2025 | Management representative |
| Spot Health, Inc. | Devices | 10/22/2025 | Documentation |
| Spot Health, Inc. | Devices | 10/22/2025 | Complaints |
