FDA 483 - Zerigo Health, Inc - August 19, 2019

CLARIFY MEDICAL INC, a medical device manufacturer in San Diego, CA, was inspected by the FDA. The inspection revealed that the firm's procedures for design change were not adequately established. Specifically, the design control procedure failed to outline how design changes are identified, documented, reviewed, validated, or verified, as demonstrated by an un-updated design specification for the Clarify Phototherapy System.