FDA 483 - Itamar Medical Ltd. - January 13, 2011

Itamar Medical Ltd. in Caesarea, Israel, was cited for multiple deficiencies related to its design control processes for a medical device project, including inadequate design plans, input documentation, output documentation, verification, transfer, and validation. Additionally, the firm failed to adequately establish procedures for complaint handling and maintain complete complaint records. These issues indicate significant gaps in the firm's quality system for device design and post-market surveillance.