iScreen Vision, Inc. – FDA 483, Sep 28, 2023

iScreen Vision, Inc. in Cordova, TN, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in quality system procedures, including inadequate complaint handling, lack of supplier control, unvalidated software for record storage, and insufficient CAPA documentation. Additionally, obsolete and unapproved documents were found in use.