FDA 483 - VicTorch Meditek, Inc - October 18, 2019

Victorch Meditek, Inc. in San Diego, CA, a medical device manufacturer, was inspected by the FDA and received a Form FDA 483 with nine observations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate process validation, lack of design controls, and insufficient supplier management. Many of these issues were repeats from a previous inspection, indicating a systemic failure to address quality system requirements.