FDA 483 - Teva Czech Industries s.r.o. - March 20, 2017

Teva Czech Industries s.r.o in Opava, Czech Republic, was inspected from March 20-24, 2017, and received one observation. The inspection revealed deficiencies in the firm's procedures for handling drug product complaints, specifically concerning the trending of "lack of effect" complaints and the quality control testing of retention samples. This indicates a moderate severity issue related to quality system controls.