FDA 483 - BioVision Technologies, LLC - December 16, 2021

BioVision Technologies, LLC, a medical device manufacturer in Boulder, CO, received an FDA Form 483 citing significant quality system deficiencies. The inspection revealed inadequate process control procedures for sterile devices, insufficient acceptance activity procedures, and failures in equipment calibration and maintenance. Additionally, the firm's device history records did not adequately demonstrate manufacturing in accordance with device master records.