The Food and Drug Administration (FDA) found five issues with Altor Safety in Valley Cottage during an inspection on March 12, according to information posted on the FDA’s website.
Inspection topics included:
- Compliance: Devices
- Postmarket Assurance: Devices
The FDA website lists the company’s citations as follows:
- ‘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.’
- ‘A design and development file was not maintained for each medical device type or medical device family.’
- ‘Processes for production and service provision where the resulting output cannot be, or is not, verified by subsequent monitoring or measurement were not validated.’
The FDA conducts regular inspections at facilities nationwide to ensure that workplaces and products meet FDA legal and regulatory standards dedicated to protecting public health. The agency publishes inspection results for the public.
According to its website, the FDA is the federal agency in charge of overseeing the safety and quality of human and animal drugs, biological products, medical devices, and tobacco offerings.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
