Biometerplususa, Inc. in Fremont was given five citations by the Food and Drug Administration (FDA) following a March 25 inspection, FDA website data shows.
The inspection addressed these areas:
- Compliance: Devices
- Postmarket Assurance: Devices
The citations detailed on the FDA website are as follows:
- ‘A risk-based approach to the control of the appropriate processes needed for the quality management system has not been applied.’
- ‘Outsourced processes that affect product conformity to requirements were not monitored and controlled.’
- ‘A system to assign unique device identification (UDI) to the medical device was not adequately documented.’
- ‘Measuring equipment was not calibrated at specified intervals or prior to use.’
- ‘Procedures for timely complaint handling do not include requirements and responsibilities for determining the need to report the information to FDA.’
The FDA conducts regular inspections at facilities nationwide to verify that workplaces and products comply with its regulations protecting public health. Inspection outcomes are made public on its website.
As outlined on its website, the FDA oversees safety and quality for human and animal drugs, biologics, medical devices, and tobacco products.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
