There was one company in a city associated with Plymouth County that received FDA citations as a result of one inspection conducted in the county in March, 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 month.
The citations in the county include:
- An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
- Procedures for corrective and preventive action have not been adequately established.
- Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
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 |
|---|---|---|---|
| Saphena Medical, Inc. | Devices | 03/04/2025 | Individual Report of Malfunction |
| Saphena Medical, Inc. | Devices | 03/04/2025 | Lack of or inadequate procedures |
| Saphena Medical, Inc. | Devices | 03/04/2025 | Lack of or inadequate complaint procedures |
