How many FDA citations were issued in cities within Hamilton County in 2025

Benjamin D. Moncarz Chief Financial Officer - FDA
Benjamin D. Moncarz Chief Financial Officer - FDA
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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.

Companies Located within Hamilton County Cities and the Citations They Received in 2025
Company NameArea of BusinessInspection DateIssue Cited
Alexei A. Grom, M.D.Drugs03/26/2025Record retention
Ashley L. Devonshire, MPH, M.D.Drugs11/20/2025FD-1572, protocol compliance
Ashley L. Devonshire, MPH, M.D.Drugs11/20/2025Case history records- inadequate or inadequate
Band ConnectDevices12/12/2025Management review – Lack of or inadequate procedures
Band ConnectDevices12/12/2025Design control – no procedures
Band ConnectDevices12/12/2025Lack of or inadequate procedures
Band ConnectDevices12/12/2025Lack of or inadequate complaint procedures
Hoxworth Blood Center University of CincinnatiBiologics09/08/2025Establish, maintain and follow manufacturing SOPs
Hoxworth Blood Center University of CincinnatiBiologics09/08/2025Proof Of Identity
Jungle Jim’s Market, Inc.Food and Cosmetics02/07/2025Develop FSVP
Kaiser Foods, Inc.Food and Cosmetics08/07/2025Scheduled process
Kutol Products Company, Inc.Drugs03/04/2025Procedures not in writing, fully followed
Kutol Products Company, Inc.Drugs03/04/2025Written procedures not established/followed
Kutol Products Company, Inc.Drugs03/04/2025Absence of Written Procedures
Kutol Products Company, Inc.Drugs03/04/2025Scientifically sound laboratory controls
Kutol Products Company, Inc.Drugs03/04/2025Microbiological testing
Kutol Products Company, Inc.Drugs03/04/2025Investigations of discrepancies, failures
Kutol Products Company, Inc.Drugs03/04/2025Second person sign off
Ohio Fertility Providers, LLCBiologics05/15/2025Completion of eligibility determination
Ohio Fertility Providers, LLCBiologics05/15/2025Eligibility not required–warning labels
Patheon Pharmaceuticals, Inc.Drugs09/26/2025Procedures not in writing, fully followed
Patheon Pharmaceuticals, Inc.Drugs09/26/2025Written procedures not established/followed
Patheon Pharmaceuticals, Inc.Drugs09/26/2025Investigations of discrepancies, failures
Patheon Pharmaceuticals, Inc.Veterinary09/26/2025Procedures not in writing, fully followed
Patheon Pharmaceuticals, Inc.Veterinary09/26/2025Written procedures not established/followed
Patheon Pharmaceuticals, Inc.Veterinary09/26/2025Investigations of discrepancies, failures
Q Labs, LLCDrugs04/25/2025Investigations of discrepancies, failures
Q Labs, LLCDrugs04/25/2025Second person sign off
Rocket SystemsFood and Cosmetics10/16/2025Quality control production, process control; material review, disposition
Rocket SystemsFood and Cosmetics10/16/2025Master manufacturing record – record requirements
Rocket SystemsFood and Cosmetics10/16/2025Batch record – required information
Spot Health, Inc.Devices10/22/2025Label to bear a unique device identifier
Spot Health, Inc.Devices10/22/2025Management representative
Spot Health, Inc.Devices10/22/2025Documentation
Spot Health, Inc.Devices10/22/2025Complaints
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.



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