There was one company in a city associated with McMinn County that received FDA citations as a result of one inspection conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is unchanged from the number of companies cited in the previous year.
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.
- Drug products failing to meet established specifications are not rejected.
The company cited had to take regulatory and/or administrative actions.
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 |
|---|---|---|---|
| Midlab Incorporated | Drugs | 09/13/2024 | Procedures not in writing, fully followed |
| Midlab Incorporated | Drugs | 09/13/2024 | Equipment Design, Size and Location |
| Midlab Incorporated | Drugs | 09/13/2024 | Failing drug products not rejected |
| Midlab Incorporated | Drugs | 09/13/2024 | Investigations of discrepancies, failures |
