Date Published:
Thu, 05/14/2009Warning Letter referring to multiple inadequate system operation procedures and validation deficiencies.
Warning Letters
Mainline Technology, 1/09
Date Published:
Fri, 01/23/2009Warning letter noting failure to validation software calculations.
Nostrum Pharmaceuticals, 4/09
Date Published:
Mon, 04/27/2009Warning Letter noting failure to validate the calculation performed by a lab instrument.
American Optisurgical, 3/09
Date Published:
Mon, 03/16/2009Warning Letter describing multiple failures, including failure to follow procedures to document and investigate software complaints, failure to validate or verify software changes, and failure to re-evaluate risk analyses for software changes.
Hernandez MD, 4/09
Date Published:
Mon, 04/20/2009Warning Letter for failure to be able to access information from an electronic diary web site.
Genzyme, 02/09
Date Published:
Fri, 02/27/2009Warning letter concerning discrepancies between programmed values in the automated system and current batch records.
Hoffman DDS, 3/08
Date Published:
Wed, 03/19/2008Warning Letter noting discrepancies between computer reports and other lists.
Behavioral Therapeutics, 4/08
Date Published:
Thu, 04/24/2008Warning Letter citation for failure to review, approve, and document a software change.
Polymer Technologies Systems, 4/08
Date Published:
Wed, 04/23/2008Warning Letter citation regarding inadequate handling of software complaints.
Philips Medical Systems, 4/08
Date Published:
Tue, 04/01/2008Warning Letter containing numerous examples of issues regarding device software validation and complaint handling.
