There was one company in a city associated with Rockland County that received FDA citations as a result of one inspection conducted in the county in March, according to the U.S. Food and Drug Administration (FDA).
No companies were cited in the previous month.
The citations in the county include:
- Written MDR procedures have not been developed.
- The quality management system was not documented in accordance with applicable regulatory requirements.
- Medical device files have not been established and maintained.
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 and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Altor Safety | Devices | 03/12/2026 | Lack of Written MDR Procedures |
| Altor Safety | Devices | 03/12/2026 | QMS not documented and maintained adequately |
| Altor Safety | Devices | 03/12/2026 | Medical device file not established and maintained |
| Altor Safety | Devices | 03/12/2026 | Design and development files not maintained |
| Altor Safety | Devices | 03/12/2026 | Process for production and service provision not validated |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
