Date Published:
Wed, 05/26/2010Warning Letter requesting plans for user training, procedures, and metrics to address the cause of reporting issues.
Regulatory Actions
Medtronic Navigation, 5/10
Date Published:
Fri, 05/07/2010Warning Letter noting CAPA failure involving software defects.
Baxter Healthcare, 6/10
Date Published:
Thu, 06/03/2010Warning Letter noting CAPA failure involving software as the root cause.
Wayne State University IRB, 4/10
Date Published:
Thu, 04/15/2010Warning Letter citing unacceptable use of software with programming defects.
Optovue, 6/10
Date Published:
Fri, 06/11/2010Warning Letter citation containing multiple examples of testing and documentation deficiencies.
AVEVA Drug Delivery Systems, 5/10
Date Published:
Fri, 05/21/2010Warning Letter citing failure to validate critical system feature.
Children’s Hospital Association Transfusion Medicine Services, 4/10
Date Published:
Thu, 04/08/2010Warning Letter listing multiple issues regarding data integrity and system access.
Deitz MD, 4/10
Date Published:
Thu, 04/01/2010Warning letter with multiple examples of data integrity and data retention issues regarding the use of clinical electronic case report forms.
Chawla MD, 3/10
Date Published:
Wed, 03/17/2010Warning letter citing delayed entry of adverse event data into the eCRF.
3CPM company, 3/10
Date Published:
Thu, 03/25/2010Warning Letter citing multiple validation and change control issues for both product and quality systems.
