FDA 483 - Precision Dose Inc. - January 28, 2019

Precision Dose, Inc., a repackager in South Beloit, IL, was cited for failing to follow established written procedures and for conducting inadequate complaint investigations. The inspection revealed issues with reviewing complaint history and managing temporary change order extensions, as well as a lack of thoroughness in investigating all reported product issues like leaking units and problematic tip caps or plungers.