FDAnews Device Daily Bulletin

Failed CAPA Procedures Earn FDA Warning Letter for HIS

March 15, 2012
Inadequate procedures, particularly corrective and preventive action (CAPA) failures, have earned Canada-based Intelligent Hospital Systems (IHS) an FDA warning letter. IHS has not established and maintained adequate CAPA procedures, agency investigators found during a Sept. 19 to 22, 2011, visit to its facility in Winnipeg, Manitoba. The FDA was not satisfied with the procedures on “how CAPA will be verified or validated to ensure effectiveness and that the actions do not adversely affect finished product,” the warning letter states.
The GMP Letter