There were three companies in cities associated with Johnson County that received FDA citations as a result of three inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 40% decrease from the number of companies cited in the previous year.
The citations in the county include:
- Procedures for design verification have not been adequately established.
- Risk analysis is incomplete.
- Procedures for design validation have not been adequately established.
All of the companies cited were involved in either Devices, Veterinary, or Food and Cosmetics sectors.
All of the companies cited should take voluntary actions to correct their managing operations.
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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Centaur, Inc. | Veterinary | 02/01/2024 | Procedures To Be in Writing |
| Centaur, Inc. | Veterinary | 02/01/2024 | Investigations of discrepancies, failures |
| Golden Boy Pies, Inc. | Food and Cosmetics | 10/24/2024 | Hazard analysis – Identification of hazard |
| Golden Boy Pies, Inc. | Food and Cosmetics | 10/24/2024 | Allergen preventive controls – Implement |
| Golden Boy Pies, Inc. | Food and Cosmetics | 10/24/2024 | Process preventive controls – Implement |
| Medical Solutions International, Inc. | Devices | 04/15/2024 | Design verification – Lack of or inadequate procedures |
| Medical Solutions International, Inc. | Devices | 04/15/2024 | Design Validation – Risk analysis not performed/inadequate |
| Medical Solutions International, Inc. | Devices | 04/15/2024 | Design validation- Lack of or inadequate procedures |
| Medical Solutions International, Inc. | Devices | 04/15/2024 | Design changes – Lack of or Inadequate Procedures |
