FDA 483 - Black Pearl Vision - February 28, 2020

Clerio Vision dba X-Cel Specialty Contacts, a medical device manufacturer in Sarasota, FL, was inspected by the FDA. The inspection revealed one observation concerning the lack of adequate approval for process validation activities and results. Specifically, the annual revalidation of the soft contact lens sterilization process was overdue and a deviation justification was unapproved.