There was one company in a city associated with Bourbon County that received FDA citations as a result of one inspection conducted in the county over the fourth quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
- Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
- Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
The company cited was involved in the Drugs and Veterinary sectors.
The company cited should take a voluntary action to correct its 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 |
|---|---|---|---|
| Avantor Performance Materials, LLC | Drugs | 11/13/2024 | Sanitation–buildings not clean, free of infestation |
| Avantor Performance Materials, LLC | Drugs | 11/13/2024 | Cleaning / Sanitizing / Maintenance |
| Avantor Performance Materials, LLC | Drugs | 11/13/2024 | Scientifically sound laboratory controls |
| Avantor Performance Materials, LLC | Drugs | 11/13/2024 | Personnel dating/signing equipment log |
| Avantor Performance Materials, LLC | Drugs | 11/13/2024 | Investigations of discrepancies, failures |
| Avantor Performance Materials, LLC | Veterinary | 11/13/2024 | Sanitation–buildings not clean, free of infestation |
| Avantor Performance Materials, LLC | Veterinary | 11/13/2024 | Cleaning / Sanitizing / Maintenance |
| Avantor Performance Materials, LLC | Veterinary | 11/13/2024 | Scientifically sound laboratory controls |
| Avantor Performance Materials, LLC | Veterinary | 11/13/2024 | Personnel dating/signing equipment log |
| Avantor Performance Materials, LLC | Veterinary | 11/13/2024 | Investigations of discrepancies, failures |



