Companies across Butler County cities saw 8 FDA citations in 2025

Sridhar Mantha, Acting Chief Information Officer of FDA
Sridhar Mantha, Acting Chief Information Officer of FDA
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There were two companies in cities associated with Butler County that received FDA citations as a result of two inspections conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).

This is a 100% increase over the number of companies cited in the previous year.

The citations in the county include:

  • You did not develop an FSVP.
  • The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
  • Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

The companies cited were involved in either Food and Cosmetics or Drugs sectors.

Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).

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 Butler County Cities and the Citations They Received in 2025
Company NameArea of BusinessInspection DateIssue Cited
Jungle Jim’s Market, Inc.Food and Cosmetics02/07/2025Develop FSVP
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
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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