Truer Medical, Inc. in Orange received a single citation during a Feb. 13 inspection conducted by the Food and Drug Administration (FDA), according to data published on the FDA’s website.
The agency’s inspection focused on:
- Compliance: Devices
- Postmarket Assurance: Devices
FDA records indicate the company was cited for failing to maintain a design and development file for every medical device type or family of devices.
The FDA regularly inspects facilities nationwide to assess whether workplaces and products are in compliance with laws and regulations aimed at advancing public health. Results from these inspections are subsequently made publicly available.
The agency’s website describes the FDA as the government entity responsible for overseeing the safety and quality of human and animal medications, biological items, medical supplies, and tobacco products.
Information in this report comes from the U.S. Food and Drug Administration. Source data is available here.
