FDA 483 - Delphinus Medical Technologies, Inc. - January 19, 2024

Delphinus Medical Technologies, Inc. in Novi, MI, a medical device manufacturer, was cited with five observations during an FDA inspection. The inspection revealed significant deficiencies in quality system procedures, including inadequate complaint handling, insufficient design change verification, improper control of nonconforming products, and inadequate software validation. Additionally, the firm failed to document justification for not reporting a correction or removal action to the FDA.