There was one company in a city associated with Litchfield County that received FDA citations as a result of one inspection conducted in the county throughout 2023, 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:
- Procedures for design control have not been established.
- Procedures for finished device acceptance have not been established.
- The device history record does not include, or refer to the location of any unique device identifier (UDI) or universal product code (UPC).
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.
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, according to its website.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| UniSoft Medical Corporation | Devices | 01/19/2023 | Design control – no procedures |
| UniSoft Medical Corporation | Devices | 01/19/2023 | Lack of or inadequate final acceptance procedures |
| UniSoft Medical Corporation | Devices | 01/19/2023 | DHR – UDI not included |
