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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Jungle Jim’s Market, Inc. | Food and Cosmetics | 02/07/2025 | Develop FSVP |
| 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 |



