MicroTransponder, Inc. of Lakeway was given one citation by the Food and Drug Administration (FDA) after a March 19 inspection, FDA data shows.
During the inspection, officials reviewed two main areas:
- Compliance: Devices
- Postmarket Assurance: Devices
The FDA record states the company was cited for the following issue: ‘An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.’
The FDA carries out nationwide inspections to assess whether facilities and products comply with regulations designed to support public health. The agency makes their inspection results publicly available.
Per its website, the FDA is tasked with monitoring the safety and quality of human and animal drugs, biological products, medical devices, and tobacco goods.
Information for this report was sourced from the U.S. Food and Drug Administration. The source data is accessible here.
