There was one company in a city associated with New Haven County that received an FDA citation 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 only citation issued in the county was delivered as ‘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.
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 |
|---|---|---|---|
| Bio-Med Devices, Inc. | Devices | 12/20/2024 | DHR – UDI not included |
