There was one company in a city associated with Clayton County that received FDA citations as a result of one inspection conducted in the county over the first quarter of 2025, 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:
- The responsibilities and procedures applicable to the quality control unit are not fully followed.
- Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
- Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
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 |
|---|---|---|---|
| Nitro Quimica Corporation | Drugs | 02/21/2025 | Procedures not in writing, fully followed |
| Nitro Quimica Corporation | Drugs | 02/21/2025 | Equipment Design, Size and Location |
| Nitro Quimica Corporation | Drugs | 02/21/2025 | Written procedures not established/followed |
| Nitro Quimica Corporation | Drugs | 02/21/2025 | Reprocessing procedures not written or followed |
| Nitro Quimica Corporation | Drugs | 02/21/2025 | Storage under appropriate conditions |
