There were two companies in cities associated with New Haven County that received FDA citations as a result of two inspections 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 device history record does not include, or refer to the location of any unique device identifier (UDI) or universal product code (UPC).
- Written MDR procedures have not been developed and implemented.
- Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
Both companies cited should take voluntary actions to correct their 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 |
| Cetro America, Inc. | Devices | 02/01/2024 | Lack of Written MDR Procedures |
| Cetro America, Inc. | Devices | 02/01/2024 | Purchasing controls, Lack of or inadequate procedures |
| Cetro America, Inc. | Devices | 02/01/2024 | Lack of or inadequate complaint procedures |
