Date Published:
Thu, 01/14/2010Warning Letter citation concerning lack of lab system security and failure to review audit trails.
Regulatory Actions
Gazda MD 11/09
Date Published:
Tue, 11/24/2009Warning Letter noting numerous discrepancies between electronic records.
Sibley Memorial Hospital, 12/09
Date Published:
Tue, 12/15/2009Warning Letter containing several examples of data integrity issues and missing electronic information.
Endotech, 10/09
Date Published:
Thu, 10/22/2009Warning Letter citing failure to validate software used in the manufacturing process
Arnold Tuber Industries, 11/09
Date Published:
Tue, 11/10/2009Warning Letter citing failure to validate manufacturing software.
Care-Tech Labs, 5/08
Date Published:
Thu, 05/22/2008483 observation noting failure to validate a lab calculation
Weartech International, 9/09
Date Published:
Tue, 09/29/2009Warning Letter noting failure to validate off-the-shelf software.
Phoenix Bio-Tech, 10/09
Date Published:
Mon, 10/05/2009Warning Letter noting failure to validate systems used in the quality system.
Phoenix Medical Devices, 9/09
Date Published:
Tue, 09/29/2009Warning Letter containing multiple software citations on topics including defect root cause analysis, validation, and vendor approval.
Cooley Dickinson Hospital, 8/09
Date Published:
Wed, 08/26/2009Warning Letter citation concerning several serious data integrity issues in blood donor systems.
