FDA 483 - Pharma Systems AB - February 17, 2016

Pharma Systems AB, a manufacturer in Knivsta, Sweden, was inspected by the FDA from February 15-17, 2016. The inspection revealed two significant observations related to inadequate quality system procedures. Specifically, the firm's complaint handling procedures lacked requirements for adverse event reporting, and its corrective and preventive action procedures did not include verification or validation of effectiveness.