FDA 483 - Amerisource Health Services LLC - June 15, 2017

ASource Health Services, a repackager/packager in Columbus, OH, was cited for multiple procedural deviations during an FDA inspection. Observations included failures to follow procedures for complaint handling and investigations, environmental monitoring, and change control. These issues indicate a lack of adherence to established quality system requirements, leading to overdue investigations and unapproved repeat testing.