FDA 483 - uniQure, Inc. - August 15, 2022

uniQure, Inc. in Lexington, MA, a Biological Contract Manufacturing Organization, was cited with three observations during an FDA inspection. The observations highlight significant deficiencies in preventing microbiological contamination during sterile drug product manufacturing, a lack of effective QA oversight for deviation investigations, and failures to follow written procedures for the storage and rejection of components, including expired materials.