FDA 483 - KDC/ONE Development Corporation, Inc. - September 21, 2017

During an inspection from September 18-21, 2017, Les Emballages Knowlton Inc. in Knowlton, Quebec, Canada, was cited for deficiencies related to laboratory records and data integrity. Observations included incomplete data from tests due to unvalidated software lacking an audit trail, and inadequate review of electronic raw data for finished product release.