The Food and Drug Administration (FDA) issued five citations to Skeletal Dynamics, Inc., located in Miami, following a device compliance inspection on April 5, 2024, according to data posted on the FDA’s website.
The FDA website indicates that the citations were delivered to the company as follows:
- ‘Documents that were not approved were observed at a location where they are being used.’
- ‘Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.’
- ‘Schedules for the adjustment, cleaning, and other maintenance of equipment have not been established.’
- ‘Procedures for acceptance of incoming product have not been adequately established.’
- ‘Procedures for device history records have not been adequately established.’
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.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
